LECZENIE RAN 2023; 22 (2)

Guidelines

Treatment of nipple wounds during breastfeeding. Position of the Center for Lactation Science and the Polish Wound Management Association

Monika Żukowska-Rubik1,2, Magdalena Nehring-Gugulska1,3, Beata Mrozikiewicz-Rakowska4, Monika Aleksy-Polipowska5,6, Natalia Żółtowska7, Roksana Kulińska8, Debora Barbay1,9

1 Center for Lactation Science, Poland

2 Lactation Clinic, Żelazna Medical Center, Poland

3 Lactation Disorders Clinic, Medical University of Warsaw Medical Center, Poland

4 Endocrinology Clinic, Postgraduate Medical Education Center, Warsaw, Poland

5 Medical Entity of the Order of Camillians, Palliative Medicine Department, St. Camillus Hospital, Tarnowskie Góry, Poland

6 The Rotmistrz Witold Pilecki Małopolska State University, Institute of Health Sciences, Oswiecim, Poland

7 “Lekarz Rodziny” NZOZ, Aneta Wojno, Mariusz Wojno s.c., Sanniki, Poland

8 “Saska Skin” Healthy Skin Center, Poland

9 Department of Neonatal and Infant Pathology, Prof. J. Bogdanowicz Children’s Hospital, Independent Public Healthcare Institution, Poland

Correspondence address

Monika Żukowska-Rubik, FTK/Centrum Nauki o Laktacji

9 Bobrowiecka St., 00-728 Warsaw, Poland, e-mail:  mzr@kobiety.med.pl

Received: 15.05.2025; Accepted: 24.05.2025

LECZENIE RAN 2025; 22 (2): 46–79

DOI: 10.60075/lr.v22i2.103

Article (PDF)

Spis treści:

Abstract
Introduction
Distinctive features of nipple wounds compared to commonly occurring hard-to-heal wounds
Causes and symptoms of nipple wounds
Treatment of nipple pain and wounds – a review of current literature
Topical pharmacological agents for reducing pain, alongside other methods
Mechanical methods to prevent and treat nipple pain and damage
Consensuses regarding wound treatment in the context of nipple wounds
Hard-to-heal wounds
Infection development in the wound
Wound management
Protocol for nipple wound management
Summary
Disclosures
References
Annex 1
Annex 2

Abstract

Nipple soreness and wounds are a common problem during lactation, especially in the first weeks after birth. These issues are associated with an increased risk of mastitis, poor weight gain in the newborn, formula supplementation, and premature cessation of breastfeeding. Prevention and early diagnosis are fundamental tasks for medical staff caring for both the mother and infant. The most common cause is the baby latching onto the breast too shallowly.

Therefore, improving the feeding technique is essential to prevent and treat nipple damage. With appropriate care, healing occurs quickly. However, in cases of hard-to-heal or infected nipple wounds, diagnostic and therapeutic measures should be taken immediately.

The position paper from the Center for Lactation Science (CLS) and the Polish Wound Management Association (PWMA) outlines practical guidelines for treating nipple wounds during lactation, considering their specific differences compared to wounds of other etiologies and in different locations. This study discusses issues related to wound infection development, the TIMERS strategy, and detailed guidelines for lactation care, essential for optimal healing.

The study proposes a classification of wounds into four categories: uninfected, at risk of infection, infected, and spreading infection from the wound to surrounding tissues. Each wound category includes appropriate therapeutic agents such as lavaseptics, antiseptics, and specialized dressings. The document also addresses indications for antibiotic therapy, the technique for taking a swab from the wound, and the most common errors in treating nipple wounds.

The described principles of treating nipple wounds are based on global and Polish consensuses in wound treatment and the many years of unique experience of Polish lactation consultants.

 

Key words: breastfeeding, sore nipples, nipple pain, nipple wound, nipple injury, damaged nipples, wound infection, antiseptics.

This document is intended exclusively for healthcare professionals, particularly physicians, midwives, and nurses who care for women and their infants during lactation. It will be particularly useful for lactation specialists.

Introduction

Nipple soreness and wounds are common issues among breastfeeding mothers. Studies from various countries show that 62–95% of women report such symptoms shortly after childbirth [1]. Pain occurs most frequently during the first week postpartum, with most women experiencing a reduction to mild discomfort within 7–10 days [2]. More than half of mothers with nipple pain also have visible nipple wounds or other skin changes [3]. Based on the number of births in 2024 (252,000) and the fact that 97% of women in Poland start breastfeeding [4], with 30% of them having nipple wounds, it can be estimated that over 73,000 breastfeeding mothers struggled with nipple wound problems.

In the study by Coca et al. [5], women with damaged nipples rated their pain intensity at an average of 6.2 points during the first week and 5.8 points later on, while women without visible damage rated it at an average of 2.7 points (on a numerical pain rating scale NRS or another scale ranging from 0 to 10 points, where mild pain is scored 1–3, moderate 4–6, and severe 7–10 points).

Nipple pain is one of the main reasons for formula feeding and premature breastfeeding cessation. In the USA, among mothers who stopped breastfeeding within the first month, one third cited nipple pain or wounds as the reason [3]. Nipple wounds are also a risk factor for mastitis [6]. The discomfort mothers experience multiple times a day when breastfeeding affects feeding quality, activity, mood, sleep, and increases the risk of depression. Disrupting the oxytocin reflex can reduce milk intake by the newborn [7].

Due to all the serious consequences of these issues, prevention is needed through educating mothers after childbirth about breastfeeding techniques, early detection of injuries, and implementing proper treatment. This responsibility lies with all healthcare professionals involved in maternal and child care, including midwives, nurses, doctors, and lactation consultants.

Distinctive features of nipple wounds compared to commonly occurring hard-to-heal wounds

A wound is a break in the continuity of the skin or the skin and the tissues beneath it. A wound of the nipple or areola usually occurs as a result of mechanical injury (pinching, pulling, rubbing, suction) caused by improper sucking technique or incorrect use of a breast pump.

Bite wounds occur as a result of being bitten by a teething infant.

Nipple wounds have several distinctive features compared to wounds of different etiology and locations. They occur in young, generally healthy women, in a well-vascularized and innervated area. Despite their usually small size of a few to several millimeters, they cause significant pain, and their healing is hindered by regular breastfeeding or expressing milk from the injured breast. Dressings must be removed every few hours before feeding, and medicinal agents must be wiped off the skin surface to ensure breastfeeding is safe for the baby. Sticky substances that are hard to wash off are not recommended.

The environment of a nipple wound is unique because it is shaped by the microbiome of the nipple skin, the milk ducts, the properties of breast milk, as well as the infant’s oral microbiome and contact with saliva. A relationship has also been discovered between the mother’s gut microbiota and her milk (the gut-breast pathway) [8].

The flora of the nipple skin is primarily composed of bacteria (commensal, symbiotic, probiotic), to a lesser extent fungi and viruses, and is integrated with the host’s immune defense. Interestingly, this flora differs from the flora of the milk and the infant’s stool. Dominant bacteria include Staphylococcus and Streptococcus species, as well as Enterobacteriaceae, Corynebacterium, Propionibacterium, Bacteroides, and others [9].

Any damage to the epidermis or dermis of the nipple (including micro-injuries) causes unfavorable changes in the microbiota composition, weakening the skin barrier and creating conditions for colonization by microorganisms of varying severity.

On the nipple, as the opening of a skin gland, commensal bacteria are present at higher concentrations than in other areas of the breast skin, so wound colonization occurs quickly. The mother’s milk and its microbiome are important protective factors [3, 10]. Breast milk contains a variety of components with anti-inflammatory, immunomodulatory, antimicrobial, and healing-supportive properties, such as interleukins, lactoferrin, lactadhesin, lysozyme, SIgA (secretory IgA), antioxidants, growth factors, interferon, vitamin A, omega-3 and omega-6 fatty acids, mucin, and many others [11, 12].

Since the nipple is continuously exposed to milk with strong bacteriostatic properties, bacterial proliferation is more difficult in that area. It has been hypothesized that histatins (small molecular weight peptides secreted into the saliva of mammals) present in the infant’s saliva may support epidermal regeneration by stimulating migration of epidermal cells, fibroblasts, angiogenesis, and additionally destroying bacteria [13].

It is worth adding that breastfeeding from an injured breast, even if the wound is infected, does not pose a risk to the breastfed infant.

Causes and symptoms of nipple wounds

The most common cause of nipple pain and damage is shallow latch, improper sucking, or clenching of the breast with the gums, usually caused by incorrect positioning of the mother or newborn during feeding or improper latching technique [14, 15]. Nipple damage often occurs during breast engorgement due to difficulties in latching caused by swelling of the areola [14]. Some infants generate excessively high suction pressure, both baseline and peak, and mothers of these infants more frequently experience nipple pain [16]. A shortened tongue frenulum is rarely the cause of nipple pain, contrary to the current trend of diagnosing ankyloglossia. The problem of a shortened frenulum affects only about 7% of infants [17], while feeding problems affect nearly 50% of these children [18]. In her study, Geddes examined infants with ankyloglossia who produced either insufficient or excessive suction pressure or overly compressed the nipple; however, milk intake remained adequate, and the mothers did not report pain. The causes of nipple damage are summarized in Table 1 [19].

Nipple damage is usually located at the nipple tip, but sometimes fissures and cracks may appear on the nipple shaft, its base, or the areola. They vary in depth and extent, ranging from epidermal lesions to deeper skin damage. Table 2 presents the types of skin lesions observed in relation to nipple damage [20–22]. The appearance usually differs for each mother, yet Woolridge et al. [23] identified some similarities and proposed a classification of nipple injuries based on their causative mechanisms:

  • compression damage – flattening of the nipple visible after removing the breast from the infant’s mouth, longitudinal wounds at the nipple tip, fissures, crust referred to as positional streaks caused by incorrect positioning of the nipple-areola complex in the infant’s mouth (Figs. 1, 2);
  • suction injury – damage to the nipple tip characterized by redness, blisters, petechiae, and star-shaped cracks on the nipple tip, caused by generating high suction pressure in the infant’s oral cavity (more often observed in mothers with low milk supply, impaired milk flow, or flat or inverted nipples).

 

Treatment of nipple pain and wounds – a review of current literature

Due to the need to protect mothers and infants from complications such as mastitis [6] or premature cessation of breastfeeding, effective treatment of nipple pain and wounds has become a subject of interest for clinicians and researchers. In previously published studies, the effectiveness of various methods has been assessed. Nipple pain and damage are generally considered together under the term “sore nipples”; however, the severity of the problem differs significantly, and many authors advocate for more precise definitions when examining study groups [5].

Breastfeeding technique and education

During breastfeeding, the nipple is positioned deeply in the infant’s mouth, with the nipple tip reaching almost to the hard and soft palate junction (HSPJ), approximately 6 mm from the HSPJ. This positioning prevents excessive compression and pressing against the bony part of the palate while stimulating the sucking reflex through the nerve endings located in this area. The nipple tip, along with the final segment of the hard palate and the back of the tongue, participates in creating the suction pressure necessary for milk extraction [24].

A recently published systematic review found that biological breastfeeding (with the mother’s body reclined, the baby positioned on her abdomen, and initiating breast latch independently) compared to traditional positions (cross-cradle, cradle, football, side-lying) reduced the risk of nipple pain and injuries. However, the study was criticized for the poor quality of the included research [25]. Bashiri did not observe any difference between the biological and cross-cradle positions regarding the frequency of nipple injuries [25]. Another study reported a higher risk of injuries when the infant’s face was incorrectly positioned at the breast (lack of contact of the nose, chin, and both cheeks) and in cross-cradle and football positions compared to the cradle and lying positions [15]. The authors hypothesize that holding the infant by the anatomical structures of the head and neck restricts the freedom of cervical spine movements and the stabilizing function of the nuchal ligament, making it difficult for the baby to touch, smell, and taste to locate the nipple. It is also possible that this causes too shallow a breast latch, jaw dysfunction, and friction of the nipple against the hard palate.

A recently presented concept of conflicting vectors – the child’s oral cavity and the breast axis – is associated with improper breastfeeding technique. According to the concept, unevenly distributed forces on the nipple surface cause stretching and pulling of the skin, leading to cytokine and histamine release, microvascular injuries, and consequently triggering an inflammatory response with interstitial swelling, nerve ending irritation, and pain. Repeated trauma results in damage (Figs. 5, 6) [3].

Education for mothers, technique guidance vs. different healing aids

The systematic review by Dennis (2014) [2] included four studies of good methodological quality involving 656 women, examining the effectiveness of nipple pain relief using expressed breast milk, a triple-component nipple ointment (mupirocin, miconazole, betamethasone), lanolin, protective shells, and hydrogel dressings. All mothers in the studies covered by the meta-analysis received guidance on how to position the baby as part of routine care. The results suggest that the absence of intervention or the use of expressed breast milk alone may be just as or more beneficial for short-term nipple pain relief compared to other methods. One of the key findings of this review is that, regardless of the treatment applied, nipple pain decreased to a mild level in most women approximately 7 to 10 days after childbirth, and mothers should be informed about this. In another large review, Niazi et al. [26] evaluated numerous interventions for nipple injuries. The primary measure taken for patients was also correcting the breastfeeding position.

Topical pharmacological agents for reducing pain, alongside other methods

Lanolin

A very popular remedy recommended to mothers is purified, hypoallergenic lanolin, cleansed of alcohols and pesticide residues. It is believed that the preparation creates a bacteriostatic barrier, maintains a moist environment, and accelerates healing. However, in the randomized study by Jackson and Dennis [1], lanolin showed no significant effectiveness in relieving nipple pain with visible nipple trauma in the early postpartum period, nor did it affect the duration of breastfeeding compared to routine care offered to mothers in the hospital after delivery. Mothers using lanolin, however, reported greater satisfaction with the treatment. In another study, Vieira et al. [27] found that applying breast milk and protective shells to the nipples was more effective than lanolin in relieving pain. The use of lanolin on wounds raises concerns due to the risk of contact allergy. Lanolin preparations intended for nipple application are purified to remove alcohols, which reduces the risk of irritation; nevertheless, they should not be used on damaged skin or by patients with atopic dermatitis (AD) [28]. Most popular ointments and creams for nipple care during lactation have not been tested for effectiveness in relieving pain.

Various methods used in the treatment of nipple pain and damage

Among the studies included in the systematic review by Niazi et al. in 2018 [26], two examined the effect of mint on nipple cracking and pain; both had acceptable design and validation, and both demonstrated the effectiveness of menthol in the form of a gel or oil. The RCT by Lavergne [29] confirmed the effectiveness of using warm water or tea tree oil compresses in relieving nipple pain associated with irritation and damage early after birth (compresses were applied 4 times a day for 15 minutes over 5 days). Due to the small sample sizes in the studies mentioned above, strong recommendations regarding their use could not be made.

The use of low-level laser therapy had a significant effect on relieving nipple pain, but its high cost limits widespread adoption of this treatment. It is worth adding that besides the methods listed earlier, other treatments for nipple wounds have been tested, which often have a regional specificity. For example, there are reports on the use of extra virgin olive oil, turmeric extract, common yarrow, honey, aloe vera, a mixture of sesame, macadamia, and apricot oils, cream made from common purslane, and even phototherapy using wavelengths in the 360–1,000 nm range. It is difficult to draw definitive conclusions from these studies regarding the most effective treatment, and the results are sometimes contradictory.

Mechanical methods to prevent and treat nipple pain and damage

Protective shells

Sometimes it is beneficial to wear protective shells after feedings, which protect the nipples from contact with breast pads or clothing. The bra should be slightly looser in this case so that the shell does not compress the breast. However, it should be remembered that the environment inside the shell is moist, and continuous use leads to skin maceration (due to prolonged moisture exposure, the skin softens and peels off). Research results regarding the effectiveness of shells are inconclusive (Fig. 7).

Protective covers (nipple shields)

A nipple shield, a protective cover worn during feeding, reduces pain for some mothers. If pain cannot be reduced by improving feeding technique or decreasing areola tension, a nipple shield can be used for a limited time, especially in cases of strong suction (high negative pressure in the newborn’s mouth) despite a deep latch [16, 30]. Use of a nipple shield may also be considered in anatomical or functional sucking disorders that do not improve immediately and where nipple wound healing progress is slow.

The impact of nipple shields on milk intake has been evaluated, but study results are inconclusive, so feeding progress and sucking efficiency must be closely monitored during shield use [29].

Moreover, it has been shown that if nipple shields are used by mothers without breastfeeding problems, it may negatively affect milk intake and nutritive sucking time; thus, nipple shields should only be recommended after careful consideration of indications [30]. The use of nipple shields has been associated with shorter breastfeeding duration, but not when supervised by lactation consultants [32, 33].

Nipple shields should be washed with detergent after each use and thermally disinfected once daily by immersion for 5–10 minutes in water at 90–100°C or in a special microwave sterilization bag. It is important to remember that lack of hygiene of the nipple shield and other equipment contacting the nipple skin increases the risk of wound infection (Fig. 8).

Consensuses regarding wound treatment in the context of nipple wounds

In the case of hard-to-heal or infected nipple wounds, improving breastfeeding technique, applying breast milk, or other methods described above will not be sufficient. Meanwhile, it is difficult to find reports on treating such wounds based on modern principles adopted in numerous consensus guidelines for wound treatment in surgery or dermatology, which discuss the use of classic lavaseptic solutions, surfactant-containing lavaseptic solutions, antiseptics, or specialized dressings [34–37]. Expert guidelines indeed concern a different type of wounds than nipple wounds, namely hard-to-heal wounds and ulcers associated with diabetic foot disease, leg ulcers, and pressure sores in typically elderly patients with multiple chronic health conditions. However, the action of lavaseptics and antiseptics is universal. These agents have been used in Poland for over a decade by lactation consultants to treat nipple wounds, showing good results in clinical observations, and the Center for Lactation Science includes them in their training protocols.

Hard-to-heal wounds

Until recently, the term chronic wounds was used to describe wounds that do not progress through the healing phases in an orderly and timely manner, with the healing process exceeding 6–8 weeks (ranging from 4 weeks to 3 months in various studies) [37]. Currently, a new definition according to Murphy is accepted, where instead of the term chronic wound, the term hard-to-heal wound is used. Any wound can be classified in this group, regardless of type or etiology. These are wounds in which factors that may impair healing exist and that do not respond to standard treatment. It has been documented that almost all contain biofilm (Fig. 9). The key moment for classifying a wound as hard-to-heal is the third day, when the wound shows increased exudate, fibrin at the wound base, and an increase in size despite ongoing treatment [39].

BIOFILM is a complex multispecies ecosystem of microorganisms enclosed in an extracellular polymeric substance – a matrix. It causes subclinical local wound infection. Within the biofilm, bacteria create a metabolically and immunologically different environment, making them resistant to antibiotics and antiseptics. Biofilm can regenerate within several hours, reaching maturity after 48–72 hours. Signs of biofilm formation include a large amount of dead tissue in the wound, shininess (glossiness), fibrinous coating, increased exudate, and unpleasant odor [35]. Counteracting biofilm proliferation involves mechanically removing the polymer matrix structure and preventing the regeneration of its mature form (Fig. 9).

In clinical observations, small nipple wounds typical in the first days after childbirth heal quickly within a few days after improving breastfeeding technique. This is supported by the bacteriostatic properties of breast milk, especially rich in bioactive factors in the first days postpartum. In a small study conducted by Nehring-Gugulska et al. in 2018 [38], the average healing time was 4.15 days, and pain resolution occurred after an average of 5.86 days. However, in clinical practice, lactation consultants often encounter nipple wounds that are hard to heal. This usually concerns extensive, deep wounds that are more prone to infection. Healing of such wounds typically takes 2–3 weeks, but sometimes even several months. It is important to remember that factors causing nipple damage can also impair its healing, such as sucking dysfunction.

Infection development in the wound

In nipple wounds, infection can develop through contact with microorganisms residing on the skin, transferred via the mother’s hands, medical staff, or present in the infant’s oral cavity. The most common pathogens are staphylococci, mainly methicillin-sensitive, rarely methicillin-resistant, enterococci, Escherichia coli, and other Gram-negative rods, streptococci [40].

Infection can spread to adjacent tissues, including breast skin, subcutaneous tissue, and the mammary gland, so it must be quickly diagnosed and treated. Infection is preceded by earlier phases of bacteria-host interaction, namely contamination and colonization (Table 3) [41–44].

Symptoms of nipple wound infection: significant increase in pain, nipple redness, swelling, warmth, swelling of wound edges, exudate – often purulent, presence of necrotic tissue [41], no healing progress despite proper breastfeeding technique and infant sucking function.

Wound management

The TIMERS strategy is used to describe wound management methods. Each letter in the acronym represents a component. Below are the individual components of the TIMERS strategy with comments regarding nipple wounds.

T – tissue debridement – wound cleaning

Lavaseptics are preparations used for washing the wound and remove physical, chemical and biological contaminants. Regular wound cleaning is essential for maintaining proper, uncomplicated healing. Classic lavaseptics include Ringer’s solution and 0.9% NaCl. According to recent studies, 0.9% NaCl may increase the proliferation of mesothelial cells, disrupt the fibrinolysis system, and decrease interleukin-6 activity, thus adversely affecting tissue regeneration; therefore, other methods should be chosen. For this reason, regular use of 0.9% NaCl in the described procedures is increasingly being abandoned.

An ideal lavaseptic should contain a surfactant, which is a surface-active agent that, among other things, reduces surface tension and disrupts the biofilm. Examples of such substances include betaine, ethylhexylglycerin, and poloxamer. Lavaseptics can also contain antiseptic substances, such as octenidine dihydrochloride, at lower concentrations than those found in antiseptics. Hypochlorites (sodium hypochlorite and hypochlorous acid) are also used in lavaseptics, although they do not contain surfactants. The preparations can take the form of a washing liquid or gel. These substances should have a broad spectrum of activity, effectively penetrate biofilm structures, and should not induce bacterial resistance.

Nipple wounds – commentary: Nipple wounds can be mechanically cleaned with a stream of lavaseptic (spraying, rinsing), by wiping with a sterile gauze pad soaked in lavaseptic, or by using a dressing specifically designed for wound cleaning (a product made of monofilament fibers). If the wound contains fibrin, dried exudate, biofilm, or crust, it is beneficial to use a gauze soaked in lavaseptic or lavaseptic gel (applied for the duration recommended by the manufacturer) to moisten, soften the coating, and then gently clean with gauze. It is important to remember that all procedures should be performed gently because of the nipple’s extensive sensory innervation.

Gao et al. described a surgical method for cleansing chronic lesions, keratotic buildups, and necrotic changes from the surface of the nipple in breastfeeding women. This method was applied when there was no improvement after two weeks of other treatments. After skin cleaning, about half of the patients experienced wound healing and pain resolution within a week, significantly more often than in the control group [45]. There are no reports on other methods of nipple wound cleaning, such as enzymatic or negative pressure therapy.

I – infection and inflammation control

To control infection and inflammation, antiseptics and dressings containing antibacterial substances are used. Sometimes, systemic antibiotic administration is necessary. Antiseptics should be used as long as there are clinical signs of local infection and discontinued when the symptoms subside, and the wound begins to heal. Antiseptics are substances with antiseptic properties; some are registered as medicines, while others as medical devices. Antiseptics exhibit bactericidal activity.

Nipple wounds – commentary: the choice of preparations depends on the wound category, as discussed below.

A gel containing an antiseptic substance, which can remain on the wound until the next feeding, can act as a dressing. The gel is applied in a thin layer, and it is advisable to use a secondary dressing, such as sterile gauze.

Lavaseptics and antiseptics are discussed in detail in Annex 2.

M – maintaining moisture balance in the wound

Specialist dressings have various properties, including providing a moist environment that promotes the proliferation and migration of epidermal cells [46]; some dressings have exudate-absorbing qualities and aim to reduce the risk of maceration of the skin around the wound; others contain antibacterial substances.

Depending on their structure, they can be divided into mesh, hydrogel, hydrocolloid, hydrofiber, foam, contact layer, and hydrogels with antibacterial substances.

Nipple wounds – commentary: A moist wound healing environment for nipple wounds, besides the mentioned benefits, reduces pain during breastfeeding by maintaining nipple skin elasticity and moisture. It also prevents crust formation, which, when disrupted during the next feeding, causes additional pain and damages the healing surface. It may be beneficial when the mother reports severe pain or the wound tends to dry out, sticking to the lactation pad or underwear. Annex 2 discusses dressings registered by manufacturers for use on nipples during lactation (Annex 2, Table I) and other types of specialist dressings that may be used for nipple wound treatment after considering the benefits and risks (Annex 2). Hydrocolloid and hydrofiber dressings adhere strongly to the wound and are unsuitable for nipple wounds.

E – protection of the wound edges and epidermization stimulation

To protect the skin from maceration, contact allergy, or irritation, it is recommended to use gentle cleansing agents with a slightly acidic pH, hypoallergenic moisturizing substances, petroleum jelly on the skin around the wound, active dressings, paraffin, epidermization-stimulating substances, and anti-inflammatory agents.

Nipple wounds – commentary: Nipple wounds are small enough that applying different substances to the wound and its edges is not feasible.

R – regeneration – supporting regenerative and repair processes

Nipple wounds – commentary: unless absolutely necessary, additional preparations from this group are not used. Due to good vascularization of the nipple, once appropriate conditions for wound healing are created through cleaning, maintaining a moist environment, and controlling infection, the wound begins to heal. An additional preparation is an extra expense and requires washing off, which is inconvenient.

S – consideration of social factors related to the patient and their family

Specialized dressings

Many types of specialized dressings are available for both non-infected and infected wounds, including various dressings designed specifically for application on nipple wounds. Among antibacterial dressings, silver ion-containing dressings are frequently used in treating difficult-to-heal wounds. However, there are no conclusive studies on their effectiveness when applied to nipples in breastfeeding mothers and their safety for infants. One study investigated silver nipple shields that significantly reduced pain and accelerated healing on days 7 and 15 after application compared to standard nipple wound care (proper feeding technique, hygiene, milk application) [47]. Hale describes the use of silver-containing products applied locally, but not on nipples during lactation [48]. In vitro studies showed that silver nanoparticles have low absorption through intact skin (0.46 ng/cm²) and damaged skin (2.32 ng/cm²). It is unknown whether silver particles are absorbed through mucous membranes when an infant suckles a breast treated with such a product or how effective nipple cleaning before feeding would be. Animal studies indicate that colloidal silver may pass into breast milk. Although silver ions in sulfadiazine cream do not absorb through the skin, the exposure level of an infant suckling a treated breast is unknown. Silver sulfadiazine preparations are not recommended by PTLR for wound treatment.

There is no clear data regarding the topical use of silver or colloidal silver products in breastfeeding women. On the other hand, silver bioavailability via oral intake is below 10%, and silver toxicity occurs only with significant, prolonged exposure exceeding the liver’s ability to eliminate it. Cases of argyria have been reported after the ingestion of several grams of the element. It seems that infant exposure from treating nipple wounds with silver-containing dressings or products would be minimal, but the lack of data necessitates caution.

Among antimicrobial dressings are those containing Manuka honey. Their use has not yet been studied in nipple wound healing. In vitro studies observed cytotoxic effects on human keratinocytes and skin fibroblasts [49]. Infants under 12 months should not consume honey. The absence of safety and efficacy data in breastfeeding mothers calls for caution.

Topical antibiotics

According to current microbiological knowledge of wounds, topical antibiotics should not be used routinely, but in selected clinical situations their use is acceptable. Topical antibiotics are applied in the treatment of local skin infections, especially on the basis of eczema or atopic dermatitis [50, 51], in ophthalmology, and for the prevention of surgical wound infections [52]. The most common applications include mupirocin, fusidic acid (which shows activity in deeper skin layers), aminoglycoside antibiotics, and others. Retapamulin and ozenoxacin are recommended for infections with MRSA strains [51].

In practice, lactation consultants use topical antibiotics for difficult-to-heal nipple wounds with good outcomes reported, but there are no studies confirming their efficacy for this indication [53]. In a small observation of 29 patients from the CLS study, topical antibiotics were used only for infected, extensive wounds and achieved better therapeutic effects than dressings without antibacterial substances; however, the sample size is too small to draw definitive conclusions [38]. If despite proper use of lavaseptics, antiseptics, or antibacterial dressings there is no progress in wound healing, the use of a topical antibiotic based on the obtained antibiogram may be justified. This is the last step before systemic antibiotic therapy, which is reserved for cases resistant to topical treatment or when infection spreads from the wound to surrounding breast tissue. Treating a small local wound infection with systemic antibiotics seems too aggressive, considering breastfeeding and the priority of topical treatments in the pharmacotherapy of lactating women [54]. However, topical antibiotics should not be used routinely as first-line treatment without indications based on an antibiogram. The use of antibacterial and antifungal agents, especially those available over the counter, without proper indications prolongs the wound healing process and causes suffering to mothers.

Substances not recommended for treating nipple wounds

  1. Povidone-iodine (absorption from the wound, accumulation in milk)
  2. Chlorhexidine (cytotoxicity)
  3. Peruvian balm
  4. Hydrogen peroxide (short action, does not eliminate microorganisms)
  5. Potassium permanganate (cytotoxicity)
  6. Rivanol (prolongs the viability of Pseudomonas aeruginosa, carcinogenic effect)
  7. Anesthesin
  8. Silver sulfadiazine (insufficient antimicrobial activity)
  9. Glucocorticosteroids (delay in healing; some preparations for skin lesions contain them, but their intended use according to the product’s characteristics is different)

The most common mistakes in treating nipple wounds

  1. Lack of improvement in feeding technique
  2. Failure to ensure proper nipple-areola latch
  3. Failure to check correct use of lactation accessories
  4. Poor hand hygiene, feeding accessories, or milk expression equipment
  5. Reassuring that “it will go away on its own”
  6. Excessive airing of nipples after feeding
  7. Failure to recognize at risk of infection or infected wound
  8. Lack of antiseptic treatment in the above-mentioned wounds
  9. Continuing the same treatment without progress within a reasonable time
  10. Lack of swab with antibiogram and untargeted treatment
  11. Using gel or hydrogel dressings on infected wounds
  12. Using lanolin and other care products (e.g., ointments with vitamins) on infected wounds (unjustified, non-targeted treatment)
  13. Using steroids in wound treatment (delaying healing)
  14. Using antifungal agents (unjustified, non-targeted treatment)
  15. Using OTC topical antibiotics

Protocol for nipple wound management

Lactation consultation

Medical history taking

During the interview, it is necessary to determine how long the injuries have been present, whether the pain is easing or worsening, assess the pain intensity using the numerical rating scale (NRS), ask under what circumstances the pain is most severe, whether the mother has noticed any purulent discharge, what treatments have been applied, and what results these have brought. Information about previous care, hygiene of the breasts, hands, and lactation accessories is also important. Lack of healing progress may result from not following recommendations.

It is necessary to gather information about the health status of the mother and child, recent antibiotic use, and the presence of skin lesions in other areas.

Factors increasing the risk of wound infection

  • Age over 35 yearss.
  • Weakened immune system.
  • Diabetes.
  • Chronic diseases (kidney failure, heart failure).
  • Malnutrition, obesity.
  • Unhealthy lifestyle, tobacco smoking.
  • Medications (glucocorticoids, insulin, cytostatic drugs, immunosuppressants).

Examination of the child

During the child’s examination, special attention should be paid to muscle tone, symmetry of the face and body, presence of skin lesions, weight gain, anatomical structure of the oral cavity, condition of the mucous membranes, tongue mobility, and sucking function.

Breast examination

When examining the breasts, assess skin coloration, tissue consistency, presence of signs of inflammation in the gland or skin and subcutaneous tissue, and axillary lymph nodes. The shape of the nipples and the elasticity of the nipple-areola complex should be evaluated. The breast examination also serves to assess the condition of the nipples, the size and depth of the wound, shininess, swelling of the wound edges, the presence of erythema and swelling of the entire nipple, the spread of erythema and swelling around the nipple, or, conversely, signs of healing (Annex 1). If there are indications, a swab from the wound should be taken.

Assessment of the feeding process

A key element necessary for diagnosis is observing the feeding process, often involving improving the position of the mother or child and the way the child latches onto the breast. Experience shows that women can breastfeed even with fairly large wounds, as long as the pain level is tolerable (7–8/10 points). Often, technique adjustments are minor but significantly improve the way the baby latches onto the breast. Even an extensive wound may not be felt by the mother during feeding if the nipple is placed sufficiently deep in the child’s oral cavity.

A lactation consultation is conducted by a properly trained person to whom the mother and child should be referred (lactation consultant – doctor, midwife, nurse). The diagnosis is established based on the interview and examination, followed by selecting the appropriate treatment.

Causal treatment

The primary goal in treating nipple pain and damage is to eliminate the cause.

A small observational study conducted by CLS in 2018 found that nipple wounds were accompanied by an average pain intensity of 7.5/10, and 90% of mothers required breastfeeding technique correction, which relieved the pain. 10% of mothers required repeated instruction during a follow-up visit. Nipple wounds treated according to the applied protocol healed within 4.15 days, and the pain disappeared completely within just under 6 days [38].

Improving breastfeeding technique is the primary action that allows most injuries to heal quickly without the need for additional methods.

The feeding position should be comfortable and stable for both the mother and the child. The baby should be held close to the mother’s body, with the head slightly tilted back, hands holding the breast from both sides, and the chin resting on the breast. Initially, the nipple is positioned at nose level, slightly raised, and directed toward the palate. When the baby tilts their head back and opens their mouth wide, the nipple is guided towards the palate. In reclined positions, when the baby lies on the mother, it can move its head forward and latch onto the breast independently. In other positions, the mother gently brings the baby close when the mouth opens wide (Figs. 10, 11).

If the areola is firm and engorged with milk, the mother should be advised to hand express a small amount of milk to reduce areola tension. Engorged breasts and a tense areola are primarily a problem during the first weeks after childbirth but can also occur in mothers with oversupply at any stage of lactation. For swelling of the breast and areola, the reverse pressure softening (RPS) technique is applied – manual drainage of the transudate fluid beneath the areola. The nipple-areola complex should be flexible enough to shape properly inside the infant’s mouth. Instruction on proper breastfeeding techniques and hand expression should be given during the hospital stay. It is the hospital staff’s duty to provide this training, as outlined in the Perinatal Care Organization Standard. However, many mothers still need help after leaving the hospital. They seek assistance from primary care midwives, but if it is insufficient, they turn to professional lactation consultants [56].

For newborns with oral cavity abnormalities, it is advisable to use specific feeding positions and manual assistance techniques, and working with an early intervention speech therapist can be helpful. In cases of anatomical or functional sucking disorders, the use of a nipple shield may be considered. A restrictive tongue-tie should be clipped without delay. In cases of asymmetry or muscle tone disorders, parents should be advised on proper infant care principles, and in some situations, consultation with a neurologist or physiotherapist may be necessary.

For mothers who express milk using breast pumps, it is essential to check the suction strength and funnel size, considering that some pumps on the market are not registered as medical devices and may have uncontrolled suction strength, some lack replaceable funnels, and some mothers have not received assistance in selecting a flange suitable for their nipple type (diameter, elasticity). Sometimes, nipple size may change after a period of expressing milk. Some types of so-called shell pumps have opaque shells, preventing the mother from adequately controlling nipple positioning. It is also worth asking the mother how she ensures the hygiene of the equipment and correcting any mistakes. During the treatment of category 2, 3, and 4 wounds, enhanced equipment hygiene is recommended [57].

An integral part of the consultation is supporting the mother, showing understanding for her complaints, appreciating her commitment to breastfeeding, and encouraging her to persevere through the challenging wound-healing period.

Treatment – supporting healing, preventing infection, treating infection

At the time of the initial assessment, it is important to consider the type of wound based on the length of the medical history, the severity of local or both local and systemic symptoms, and whether any treatment has been applied so far – or if none has been given.

Recommendations for the mother must be simple and possible to perform repeatedly throughout the day – in accordance with the feeding schedule. Feeding involves the necessity of removing applied substances (which is troublesome and painful and concerns most preparations or dressings) and reapplying them after feeding. Moreover, these products are not cheap, must be financially accessible to the patient, and are usually needed for no longer than 1–3 weeks. Therefore, it is important to avoid using too many preparations. Dressings for breastfeeding women are not reimbursed because nipple wounds do not meet the criteria of chronic wounds as defined by the National Health Fund (NFZ).

It is important to monitor the course of treatment at short intervals and to change the strategy if necessary. The choice of treatment depending on the wound category is described in Table 4, Figures 12–15. Systemic antibiotic therapy is rarely necessary in the treatment of nipple wounds; indications are listed in Text box. The optimal approach is to select antibiotics according to the antibiogram obtained from a wound culture. In special cases, empirical treatment may be started – in such cases, first-generation cephalosporins are used, as the most common pathogen causing infection is methicillin-sensitive Staphylococcus aureus (MSSA).

It should be remembered that medicinal agents will act in combination with the previously described interventions, eliminating the causative factor of the injury.

Situations requiring systemic antibiotic treatment for infected nipple wounds

  • Lack of improvement despite the proper implementation of all stages of local treatment
  • Spread of infection to the areola
  • Spread of infection to the skin of the breast, subcutaneous tissue, and glandular tissue
  • Systemic infection symptoms

Table 5 lists antiseptic substances and their characteristics. Tables 6 and 7 describe the technique for collecting a swab from a nipple wound and skin lesions (Fig. 16). The indications for collecting a swab from a nipple wound or from the skin of the nipple and areola, as well as for collecting milk for culture in the case of mastitis, are presented in Text boxes.

Bite from a teething infant

Bites to the nipple or areola by a teething infant require prompt treatment. Management follows category three recommendations – a swab should be taken, the wound should be cleaned with a preparation containing a surfactant and antiseptic, a dressing with an antibacterial agent should be applied, and if healing does not occur within a few days, a broad-spectrum antibiotic or one based on an antibiogram should be administered. The substances of choice for a breastfeeding mother with a bite wound are sodium hypochlorite and hypochlorous acid, which can be used for wound irrigation. When used at low concentrations, hypochlorites offer high antimicrobial efficacy combined with safety, and are non-cytotoxic to healthy tissue. Additionally, hypochlorites have anti-inflammatory and antipruritic properties and are pH neutral (Fig. 17) [58, 59, 61].

Figure 18 presents example of infected niepple wound healing.

Indications for taking a swab from the nipple wound or skin of the nipple and areola include [57]

  • Signs of wound infection
  • Hard-to-heal wounds
  • Persistent nipple pain despite improved latching technique
  • Skin changes on the nipple or areola such as erythema, oozing, scaling, cracking

Indications for taking a breast milk sample for culture in cases of mastitis

No improvement after 3 days of empirical antibiotic therapy

  • Severe, septic course of mastitis
  • Suspected nosocomial infection
  • Recurrence of mastitis (symptoms reappearing in the same breast within 3 months of the last occurrence)
  • Subacute mastitis
  • Allergy to multiple antibiotics

The use of medicinal agents and breastfeeding

Medicinal agents applied to the nipple skin should be used after feeding the baby. Creams or ointments containing antibiotics should be applied before longer breaks in feeding, such as at night or before going for a walk. Antiseptics without residual effect do not need to be rinsed off before feeding, whereas other preparations should be rinsed off with pre-boiled water. To clean the breast before feeding when a cream or ointment has been applied, use expressed breast milk (squeezed onto a gauze pad) or a product with a slightly acidic pH. Similarly, the nipple surface should be cleaned after removing the dressing to minimise the infant’s exposure to medicinal substances and, for example, mineral oils used as a base [64, 65].

Hygiene rules

During breastfeeding, especially when nipples are cracked or injured, hygiene rules must be followed:

  • wash your hands before breastfeeding;
  • wash your hands before dressing the wound;
  • wash the breasts during your regular body hygiene routine (at least once a day), using water and a mild soap, or preferably a cleanser with a slightly acidic pH (syndet) [66]. The use of soaps or products containing antibacterial agents for washing the breasts is not recommended. Washing the breasts before each feeding is also not recommended;
  • wash and thermally disinfect accessories that come into contact with the breast (nipple shields, breast pump parts) once a day, and after each use for category 2, 3, and 4 wounds (increased hygiene of lactation equipment). Thermal disinfection is done by soaking the equipment for 5–10 minutes in water at 90–100°C;
  • frequent replacement of nursing pads;
  • hand disinfection by medical staff prior to contact with the mother or infant;
  • hand hygiene by family members before contact with the mother, infant, or nursing equipment

Pain management

The mother should be offered short-term analgesics, selecting the safest options for use during lactation (Hale’s classification L1–2), such as paracetamol or NSAIDs (ibuprofen, ketoprofen, diclofenac). Another method of pain relief involves manual expression of milk before breastfeeding to stimulate the milk ejection reflex and trigger the analgesic effects of oxytocin in the central nervous system. Improving breastfeeding technique is of fundamental importance.

Temporary cessation of breastfeeding

Breastfeeding is safe for the infant but may be too painful for the mother. In such cases, a temporary cessation of breastfeeding can be considered for several hours, up to several days, with regular expression of milk and feeding the infant with expressed milk until the wounds heal, provided that milk expression is less painful than breastfeeding, does not disrupt the wound, and ensures effective breast emptying.

General condition of the mother

Special attention should be given to women with a complicated medical history, in whom wound healing may be impaired and the risk of infection is higher than in the healthy population (see Factors increasing the risk of wound infection in Text box). Delayed wound healing is an indication to assess the mother’s overall health and to perform additional tests, for example, to rule out anemia or abnormal blood glucose levels. Nutritional assessment is also necessary, as approximately half of Polish mothers follow elimination diets during lactation. They most commonly avoid dairy products, including eggs, as well as many other sources of energy, protein, and vitamins, allegedly to protect the infant from colic, allergies, and other conditions. Such nutrient-deficient diets may delay wound healing [67]. Malnutrition increases the risk of wound infection. According to recommendations, a patient with a chronic wound should receive 30–35 kcal/kg body weight/day (no less than 1,800 kcal) and an adequate amount of protein (1.5–2.5 g/kg body weight), carbohydrates (55–60%), and fats (20–25%).

Summary of treatment rules for nipple wounds in breastfeeding mothers

Correction of breastfeeding technique and reduction of areolar tension before infant latch (if indicated)

  • Appropriate interventions to improve the infant’s sucking function when indicated (consultations with lactation consultants, speech therapists, physiotherapists, frenotomy)
  • Selection/correction of the flange size and pump strength to ensure the mother’s comfort during milk expression
  • Hand, breast, and pump equipment hygiene
  • Use of lavaseptics, antiseptic agents, specialized dressings, antibiotics as appropriate to the wound category
  • Pain management; in exceptional cases, breastfeeding interruption for 1–2 days with continued milk expression and feeding expressed milk
  • Proper maternal nutrition

Tasks – what treatment would you apply?

Task 1 (Fig. 19): Wound healing has not progressed for 3 weeks; at the nipple base, there is a fissure affecting most of the nipple’s circumference, with varying depths, exuding discharge, and severe pain; the mother is close to stopping breastfeeding. So far, she has been applying breast milk to the wound after feedings and using hydrogel dressings. Breastfeeding technique is correct.

Task 2 (Fig. 20): A deep wound present for one month involving the tip and sides of the nipple, covered with biofilm, swollen wound edges, oozing discharge, nipple swelling, and pain. The mother breastfeeds several times a day, but feeding is very painful, so she expresses milk more often. So far, she was recommended nursing creams, protective shells, and used an antiseptic for several days.

Differentiation of lesions located on the nipples

In breastfeeding mothers, injuries usually occur due to incorrect breastfeeding or breast pump use techniques. However, nipple lesions may also be caused by systemic diseases, e.g., viral infections (Herpes simplex, Herpes zoster, Varicella zoster), bacterial infections (syphilis, gonorrhea), or systemic conditions (psoriasis, ichthyosis, eczema, atopic dermatitis). Oncological vigilance is essential for lesions that do not heal within the expected time, and patients should be referred for diagnostics (e.g., Paget’s disease of the breast). An algorithm on nipple pain and injury collects key information for managing painful and wounded nipples (Fig. 21). It briefly addresses other common lactation issues relevant to differentiating nipple pain causes.

Summary

Nipple wounds are a frequent problem, especially shortly after delivery, and one of the main reasons mothers prematurely stop breastfeeding. Knowledge of the basic principles of nipple wound treatment is essential for all healthcare workers caring for the mother or infant during lactation at various levels of the healthcare system and in different roles, including midwives, nurses, lactation consultants, gynecologists, neonatologists, pediatricians, and family doctors. Their expertise and cooperation serve public health. Improving breastfeeding technique and ensuring the nipple-areola complex is compliant enough to allow the infant to latch deeply are fundamental to treatment. It is important to frequently monitor the progress of wound healing to promptly respond to signs of emerging infection. In the study, the authors highlight when maternal milk, modern lavaseptics, antiseptic substances, or specialized dressings can be used for wound treatment depending on the wound category, taking into account the specific location of these wounds and the contact between the baby’s oral cavity and the treated breast.

Solution

Task 1 (Fig. 19): Category 2B wound, hard to heal, the following should be recommended:

  • collect a wound swab for culture;
  • option 1 – cleansing after feeding with a lavaseptic containing surfactant and antiseptic; between feedings apply foam dressing;
  • option 2 – surfactant and antiseptic gel applied in a thin layer after feedings, left until the next feeding;
  • pain medication;
  • hygiene measures;
  • follow-up after 4 days.

Task 2 (Fig. 20): Category 3 wound, the following should be recommended:

  • improve breastfeeding technique!
  • collect a wound swab for culture;
  • cleansing the wound with a surfactant-containing lavaseptic after breastfeeding/expressing, ideally in the form of a compress made from gauze soaked in the solution; a first-line antiseptic is optimal for infected wounds;
  • cleaning the wound surface of biofilm once daily;
  • between feedings, dressings containing antibacterial agents and monitoring of discharge;
  • pain medication;
  • hygiene (increased hygiene of expression equipment);
  • follow-up after 4 days.

Disclosures

Beata Mrozikiewicz-Rakowska: consultations and lectures for: Convatec, Hartmann, Schulke, Smith@Nephew, Urgo.

Monika Aleksy-Polipowska: consultations and lectures for: ConvaTec, Verco, Schulke, Urgo.

The other authors declare no conflict of interest.

This research received no external funding.

Approval of the Bioethics Committee was not required.

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Annex 1

General principles of wound assessment

Wound assessment

The wound assessment triangle is a fundamental tool, especially useful for beginners starting to manage wound care. Assessment is conducted as follows:

  • wound bed,
  • wound edges,
  • surrounding skin.

Assessment of the wound bed

  1. Tissue type.
  2. Exudate.
  3. Infection.

Assessment of wound edges

  1. Maceration.
  2. Dryness.
  3. Epibole.

Assessment of surrounding skin

  1. Maceration.
  2. Excoriation.
  3. Dry skin.
  4. Hyperkeratosis.
  5. Induration.
  6. Eczematous lesions.
  1. Tissue type
  •  
  • Liquefactive necrosis.
  •  
  •  
  1. Exudate

Amount: none; small; moderate; large.

Type: watery; dense; clear; cloudy; purulent; pink/red.

  1. Infection

Local: increased pain; erythema; swelling; localized warmth; increased exudate; friable granulation tissue; unpleasant odor; epibole.

Spreading/systemic: intense erythema; fever; abscess/pus; wound dehiscence; cellulitis; general weakness; leukocytosis; lymphangitis.

Glossary

Dryness – low moisture level preventing the formation and migration of cells necessary for new tissue growth. Keratinocytes become flat and flaky. The skin feels rough and peels.

Eczematous changes – inflammatory condition characterized by itching, redness, and rash.

Epibole – epidermal tissue building up inward into the wound rather than covering its entire surface. It may occur in wounds with an inflammatory basis, including those caused by tumors, and can result in delayed healing if appropriate measures are not taken.

Epithelializing – pink tissue at the final healing stage, when epidermal cells appear on the wound surface.

Excoriation – damage to the skin surface caused by repeated trauma such as scratching or abrasion

Exudate – inflammatory fluid discharged from the wound; during a normal healing process, the amount of exudate increases in the inflammatory phase to cleanse the wound and maintain optimal moisture, which accelerates healing. In chronic wounds, exudate has a different biochemical composition, leading to the breakdown of protein structures in the wound and further tissue degradation.

Granulation – new, red tissue and capillaries forming on the wound surface during healing.

Hyperkeratosis – excessive thickening of the epidermis.

Induration – thickened and hardened skin or soft tissue, especially in areas previously subjected to friction or pressure.

Infection – the presence of bacteria and other microorganisms in sufficient quantities to damage tissue and impair healing. Clinical signs of infection may be absent in patients with immunosuppression, perfusion disorders, or chronic wounds.

Liquefactive necrosis – yellow, fibrous tissue composed of fibers, pus, and protein material.

Maceration – a process during which the tissues at the wound edge soften due to prolonged exposure to moisture from the wound exudate. The affected tissue is usually white in color.

Necrotic tissue (dead tissue) – black, dead tissue containing dead cells and remnants of tissue resulting from the breakdown of dying cells.

Undermining – tissue breakdown or ulceration spreading beneath the wound edge, resulting in a wound base wider than the skin surface opening.

Annex 2

List of lavaseptics, antiseptics, and specialized dressings

Lavaseptics, which may be sterile or non-sterile medical devices, are classified as products used for care, cleansing, washing, and rinsing of the skin or mucous membranes. They are used for wound cleansing and the removal of fibrin, clotted secretions, and scabs. They should be used according to recommendations, including prior to the application of the proper antiseptic.

Lavaseptics can be divided into those containing surfactants (substances that facilitate cleansing by reducing surface tension of secretions or bacterial biofilm on the wound surface) and those without surfactants. Some lavaseptics also contain antimicrobial substances in lower concentrations than antiseptics. Lavaseptics may come in liquid or
gel form.

The use of soap and water for wound cleansing is not recommended due to the high, non-physiological pH of soap, which promotes tissue tension and dryness.

The preparations and dressings listed below are commercially available and have been described based on the IFU and SmPC, in accordance with the data available at the time of publication.

Group 1. Lavaseptics without surfactants

NaCl 0.9%

Form: solution.

Sterility: depends on the manufacturer and packaging.

Notes Scientific literature reports the irritating effect of NaCl 0.9% on tissues.

Suggested use: for short-term rinsing of the nipple.

Ringer’s solution

Form: solution.

Sterility: depends on the manufacturer and packaging.

Notes: none.

Suggested use: for rinsing the nipple.

Solutions containing low concentrations of hypochlorous acid and/or sodium hypochlorite

The anti-inflammatory effects of hypochlorite solutions have been proven, and they are used in dermatology, e.g. in atopic dermatitis. Literature indicates their ability to reduce microbial load on tissue surfaces through rinsing. Research results on their antimicrobial activity are inconsistent due to the lack of a residual effect, as hypochlorites break down and deactivate. On the other hand, this also contributes to their high safety profile. Hypochlorites are substances with high oxidative potential, which is the main mechanism responsible for destroying microbial structures. Human cells are not sensitive to low concentrations of around 40/50 ppm, as they possess a natural detoxification mechanism. This results from the natural production of HOCl during the process of phagocytosis.

Microdacyn

Form: solution. Medical device.

Sterility: none – the manufacturer guarantees microbiological purity (statement available).

Contraindications and safety measures: see IFU. Hypersensitivity to any component of the formulation. Do not ingest.

Notes The manufacturer recommends a contact time of 15 minutes.

Suggested use: for rinsing wounds on the nipple.

Granudacyn

Form: solution. Medical device.

Sterility: none; the manufacturer guarantees microbiological purity.

Contraindications and safety measures: see IFU. Hypersensitivity to any component of the formulation. Do not ingest.

Notes The manufacturer recommends a contact time of 15 minutes.

Suggested use: for rinsing wounds on the nipple.

Granusept

Form: solution. Medical device.

Sterility: none; the manufacturer guarantees microbiological purity

Contraindications and safety measures: see IFU. Hypersensitivity to any component of the formulation. Do not ingest.

Notes The manufacturer recommends a contact time of 15 minutes.

Suggested use: for rinsing wounds on the nipple.

Aquitox D

Form: solution. Medical device.

Sterility: none; the manufacturer guarantees microbiological purity.

Contraindications and safety measures: see IFU. Hypersensitivity to any component of the formulation. Do not ingest.

Notes The manufacturer recommends a contact time of 2 minutes.

Suggested use: for rinsing wounds on the nipple.

Group 2. Lavaseptics containing surfactants

Octenilin® Wound Irrigation Solution

Form: irrigation solution.

Ingredients: octenidine, ethylhexylglycerin, glycerol.

Surfactant: ethylhexylglycerin.

Sterility: yes.

Antimicrobial effect.

Medical device. Studies show that the concentration of octenidine used in the medical product Octenilin exhibits bactericidal activity – reducing bacterial count by 5 log levels – against both Gram-positive and Gram-negative microorganisms as early as 15 seconds after exposure (incubated with exudate).

Contraindications and safety measures: see IFU. The product is non-irritating, non-allergenic, painless to use, non-toxic to tissue, and does not hinder granulation or epithelial regeneration. The solution has good tissue tolerance. Octenilin® Wound Irrigation Solution, due to its low surface tension, provides excellent moisturizing and cleansing properties, even in hard-to-reach areas such as fissures, cracks, and the inside of wound pockets. For external use only on skin wounds. Interactions: Do not use in combination with anionic surfactants or other wound-cleaning agents such as soaps, ointments, oils, enzymes, etc., as this may adversely affect its preservation. Do not use in combination with PVP-iodine, as this may cause discolouration and reduce the antiseptic effect of PVP-iodine. If an allergy or suspected allergy to one or more ingredients is present, Octenilin® Wound Irrigation Solution must not be used. If unsure, consult your physician. To avoid potential tissue damage, Octenilin® Wound Irrigation Solution must not be applied to hyaline cartilage, eyes, ears, nose, bladder, or the abdominal cavity. Do not use for infusion or injection. Do not ingest. To prevent tissue injury, do not inject or apply the product under pressure into tissue. Proper drainage from wound cavities must always be ensured.

Notes: Octenidine is not absorbed into the bloodstream, and the risk of its presence in breast milk is very low. Residual effect. Time of action – 1 minute.

Suggested use: for rinsing nipple wounds to cleanse the area and reduce microbial burden. Due to the residual effect, rinsing before breastfeeding is recommended.

Prontosan® Wound Irrigation Solution

IFU dated 22.04.2025 – Pregnancy and lactation There is no evidence of mutagenic or embryotoxic effects related to the ingredients of this product. However, due to the lack of adequate clinical studies and experience, Prontosan Wound Irrigation Solution should not be used in pregnant or breastfeeding women. 

SutriSept® Płyn na rany [Wound cleansing fluid]

Form: wound cleansing fluid.

Ingredients: Water, poloxamer 188, polyhexamethylene biguanide (polyhexanide, PHMB) 0.1%.

Surfactant: poloxamer 188.

Sterility: no.

Antimicrobial effect. Medical device.

Contraindications and safety precautions (IFU): Polyhexanide is not absorbed into the systemic circulation, and the likelihood of it being excreted into breast milk is nearly zero. Due to the lack of clinical studies and experience in using the product in pregnant and breastfeeding women, the SutriSept® Wound cleansing fluid should be used with caution, following a medical assessment.

Newborns and infants: Due to insufficient clinical data for newborns and infants, the SutriSept® Wound cleansing fluid should only be used under strict medical supervision.

To date, no adverse reactions have been reported for the SutriSept® Wound cleansing fluid, but rare cases (frequency less than 1 in 10,000) of anaphylactic shock caused by polyhexanide have been reported. The SutriSept® Wound cleansing fluid may cause allergic reactions such as itching (urticaria) and rash. Do not use the product in individuals with hypersensitivity to this substance. In very rare cases, a mild burning sensation may occur after applying the SutriSept® Wound cleansing fluid, but it subsides within a few minutes.

The SutriSept® Wound cleansing fluid is compatible with all modern wound dressings. 

Do not use the SutriSept® Wound cleansing fluid in the following cases:

it is not suitable for application to hyaline cartilage or for use in aseptic joint surgeries, in the middle or inner ear, or in the eyes. It must also not be applied to the central nervous system or the meninges. If used in combination with anionic surfactants, soaps, creams, oils, or enzymes, these substances must be thoroughly removed from the wound surface before applying the product.

For external use on the skin only.

The SutriSept® Wound cleansing fluid must not be administered via intravenous infusion or injection.

Note: PHMB is not absorbed into the bloodstream, and it is unlikely to pass into breast milk. Residual effect. Time of application – 15 minutes.

Suggested use: for rinsing nipple wounds to cleanse the area and reduce microbial burden. Due to the residual effect, rinsing afterwards is advised.

Group 3. Hydrogel with an antimicrobial agent

To be used as a moisturising wound dressing.

Medical device.

Contraindications and safety precautions: same as for solutions.

Warning. For external use only, under the supervision of a medical proffesional. No studies have been conducted in breastfeeding women. Apply to the nipple after breastfeeding. The product may remain on the wound surface until the next dressing change. Before feeding the baby, the gel must be thoroughly rinsed off the nipple, as hydrogels liquefy upon contact with water.

Aquitox 0.03%

Granudacyn 0.004%

Microdacyn Hydrogel 0.006%

Hydrogels with added surfactant:

Octenilin gel 0.05% (+ oxadermol)

SutriSept gel 0.1% (+ poloxamer)

The percentage indicates the concentration of the antiseptic agent.

Group 4. Antiseptics

Octenisept® Spray

Contains a surfactant – betaine.

Composition: octenidine 0.1%, phenoxyethanol 2%, betaine.

Medication for the disinfection of wounds, mucous membranes, and skin.

Indication: for superficial wounds, especially in cases of infection or suspected colonisation with multidrug-resistant strains.

Time of action – 1 min.

To be used as a spray, swab, or compress for up to 5 minutes.

Commonly used for everything from ulcers to acute wounds.

Available in various forms: liquid, gel, cleansing emulsions, dressings.

Octenidine has a high safety profile and can be used from the first day of life.

It shows a broad-spectrum bactericidal effect against multidrug-resistant Gram-positive and Gram-negative bacteria, fungi, and yeasts.

Compared to other substances, it has an effective bactericidal action even with a short contact time and low concentration, and remains active in the presence of protein load (exudate, blood) – 30 seconds.

It has anti-inflammatory and immunomodulatory properties that support the healing process.

It shows a residual effect.

Povidone-iodine (source: Braunol 7.5% skin solution, SmPC)

Does not contain a surfactant.

Medication.

During pregnancy and breastfeeding, Braunol – like all iodine-based products – should only be used under strict medical indication, and its use should be very limited. After use, assessment of the infant’s thyroid function is recommended. If hypothyroidism is diagnosed, early hormone therapy should be initiated until normal thyroid function is restored. During breastfeeding, care should be taken to prevent accidental entry of Braunol into the child’s mouth from the treated areas of the mother’s body.

Contraindications for the use of PVP-I include hypersensitivity to the active substance, toxic goiter, Hashimoto’s disease, Duhring’s disease, and peritoneal cavity irrigation.

It passes into breast milk, and the concentration of iodides in breast milk increases to a greater extent than in blood serum.

Antiseptics containing povidone-iodine should not be used during pregnancy and breastfeeding.

Due to potential side effects, it is not recommended for use on cracked or wounded nipples.

Povidone-iodine (source: SmPC BETADINE, 100 mg/ml, skin solution)

Does not contain a surfactant.

Medication.

The product may only be used after the second month of pregnancy and during breastfeeding if a thorough diagnosis has been made and there are strict indications for its use. In such cases, thyroid function in both mother and child should be monitored. The duration of treatment must be limited to the shortest possible time.

Iodine crosses the placenta and is excreted in breast milk. Moreover, iodine reaches higher concentrations in breast milk than in serum. Povidone-iodine may cause transient hypothyroidism in the newborn.

The infant must be strictly protected from ingesting the product!

Povidone-iodine should not be used during pregnancy and breastfeeding.

Due to potential side effects, it is not recommended for use on cracked or wounded nipples.

SPECIALIZED DRESSINGS

Specialist dressings whose use may be considered for nipple wounds, after weighing the benefits and risks

Specialist dressings are classified as medical devices. They should be used in accordance with the instructions for use, and under the supervision of a medical proffesional.

RECOMMENDATION: After removing the dressing, the wound and surrounding skin should be thoroughly cleansed. Follow the standard protocol for breast preparation before breastfeeding.

It is important to remember that nipple wounds during lactation differ in nature from other chronic or hard-to-heal wounds. When selecting a specialist dressing for these wounds, this distinction must be taken into account! Potential benefits of using dressings include the creation of a moist healing environment, absorption of exudate, antimicrobial action, and protection of the wound from external exposure. Potential drawbacks include the need to frequently remove the dressings for breastfeeding and to clean off any residue from the nipple surface, which may damage healing tissue and cause pain. Therefore, the benefits and risks must be assessed on a case-by-case basis.

The Annex includes examples of dressings available at the time of publication.

Group 1. Sterile hydrogel dressing

Dressing indicated, among other uses, for the treatment of “abrasions and other superficial skin injuries”

The Aqua-Gel® hydrogel dressing is a specialist dressing. It is composed of 91.5% pharmacopeia-grade water and natural and synthetic polymers that are permanently cross-linked using an electron beam. These polymers form a network that provides the dressing with a stable structure.

Thanks to its hydrogel structure, the dressing has a soothing and analgesic effect, improving patient comfort.

It supports autolytic wound debridement.

The dressing is hypoallergenic and non-sensitising. Its ingredients are fully biocompatible.

The dressing’s transparency is an advantage during treatment, allowing for continuous monitoring of the wound and early detection of any adverse changes.

Important: prolonged use of a sterile hydrogel dressing may lead to maceration of the skin surrounding the wound.

The frequency of dressing changes depends on the amount of wound exudate.

When changing the dressing, the wound should be rinsed with a wound decontamination solution; the manufacturer recommends, for example, Microdacyn.

Group 2. Mesh dressings

Main characteristics:

  1. Do not contain antimicrobial agents.
  2. Sterile.
  3. Protect the wound from drying out while allowing free exudate transfer to the secondary dressing.
  4. Require a secondary dressing, such as a sterile gauze pad, high-absorbency dressing, polyurethane foam, and fixation with adhesive tape or clothing.
  5. The dressings form a breathable protective barrier.
  6. They enable unrestricted drainage of exudate to the secondary dressing.
  7. Intended for superficial wounds without signs of infection!

Mesh dressing impregnated with neutral ointment

A mesh dressing that does not contain any active substances. (GRASSOLIND).

Mesh dressing impregnated with paraffin

Paraffin dressing. Made of sterile gauze coated with white paraffin. It is compatible with ointments, including those containing antibiotics. Made from high-quality cotton gauze providing effective wound protection. (JELONET).

Gauze dressing impregnated with paraffin. Helps maintain proper wound moisture, prevents drying and maceration of the wound edges. The neutral properties of paraffin allow the dressing to be used in combination with other products containing medicinal substances or antiseptic agents. (PARAFFINET).

Mesh dressing – various structures

Thin, hydrophobic tulle mesh dressing, impregnated with a neutral, non-active, and non-allergenic ointment. Ensures good ventilation. (ATRAUMAN). Made from smooth viscose knit impregnated with an oil-in-water emulsion; mesh size 1×1 mm to prevent ingrowth of granulation tissue. It is a contact layer dressing with moisturizing and emollient effects that prevents adherence to the wound surface. (ADAPTIC).

A hydrogel dressing in the form of a polyester fiber tulle mesh impregnated with a coating mass consisting of a polymer matrix. This is a flexible fixing mass that allows flexible shaping. Additional components include petrolatum and hydrocolloid. (LOMATUELL PRO).

A non-adherent dressing made of tulle mesh impregnated with a polymer matrix containing fat and hydrocolloid. In contact with wound fluids, hydrocolloid particles form a gel, which, together with petrolatum, creates an amphiphilic layer (hydro-lipo-flow). This promotes wound healing and prevents adhesion to the wound. The dressings are sterile and individually packed. (LOMATUELL® PRO). 

Group 2. Mesh dressings containing antimicrobial substances

Features

They contain antimicrobial agents, mainly silver particles.

Recommended for wounds showing signs of infection or at risk of infection.

The mesh form allows cutting the dressing to fit the wound size, ensuring efficient use and reducing the risk of maceration of the skin surrounding the wound.

+ same as in Group 1

Antibacterial dressing with neutral ointment containing metallic silver

A low-cytotoxicity dressing with metallic silver for infected wounds or those at risk of infection. Recommended as a complementary treatment for infected wounds or wounds exposed to contamination.

Based on research, the manufacturer recommends it for use against Gram-negative and Gram-positive bacteria, including strains of Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and Bacillus subtilis.

The dressing’s carrier material consists of a hydrophobic polyamide mesh impregnated with an ointment containing plant-derived fatty acids. The ointment cares for the wound edges and maintains their elasticity. This specialist dressing contains no vaseline or other paraffin-based components, preventing adherence to the wound and allowing painless removal. (ATRAUMAN AG).

Antibacterial dressing impregnated with silver salts, made using lipid-coloid technology

A dressing impregnated with silver salts. It contains a healing matrix with silver, made of polyester mesh impregnated with hydrophilic particles (carboxymethylcellulose), vaseline, cohesive polymers, and silver salts.

Bactericidal efficacy against bacteria (Pseudomonas aeruginosa, Staphylococcus aureus).

Suitable for deep and fissure wounds.

Indicated for treatment of wounds with risk or signs of local bacterial infection with small amounts of exudate. (UrgoTul Ag/Silver).

Dressing with nanocrystalline silver

Exhibits bactericidal activity. The dressing is intended for the treatment of superficial, hard-to-heal wounds with a tendency to exude, as well as wounds located in areas difficult to dress.

The nanocrystalline silver coating releases silver ions. Polyethylene mesh with a high-density weave. Low adhesion facilitates easy dressing removal.

Recommended for infected as well as infection-prone superficial and deep wounds. (ACTICOAT FLEX 3).

Dressing with ionic silver (1.2%), made using hydrofiber™ technology. antibiofilm dressing – contains ethylenediaminetetraacetic acid (EDTA) and benzethonium chloride (BEC)

It consists of two layers made from sodium carboxymethylcellulose fibers, reinforced with stitching. It is created using the More Than Silver™ and Hydrofiber™ technologies.

Recommended for wounds with moderate and/or heavy exudate and biofilm formation.

Forms a coherent gel when in contact with exudate. This creates an ideal environment supporting the wound healing process. Thanks to Hydrofiber™ technology, the dressing locks excess exudate, bacteria, and biofilm within its structure.

For deep wounds, fill only up to 80% of the wound cavity with the dressing. This is due to the dressing’s properties, which initially contract slightly upon contact with exudate during gel formation, then expand to fill the empty space.

It requires the use of a secondary dressing. (AQUACEL AG +EXTRA).

Group 3. Foam dressings without antimicrobial substances

Features

  1. Allow the skin to breathe.
  2. Protect the wound from drying out, absorb exudate through various mechanisms – depending on the structure of the dressing.
  3. Intended for superficial wounds without signs of infection!
  4. Versions available – adhesive and non-adhesive. NON-ADHESIVE versions must not be cut.
  5. Can be used as primary dressings (for shallow wounds, e.g. abrasions) or as secondary ones, to cover e.g. a mesh dressing with an antimicrobial substance.
  6. All foam dressings have cushioning properties.
  7. They are waterproof, transparent, and flexible, which increases user comfort.
  8. They do not stick to the wound, making dressing changes painless.
  9. They protect the wound from the entry of bacteria and microorganisms.
  10. They help maintain an optimal environment for wound healing.

Multilayer foam dressing for exuding wounds

Foam dressing with a wound contact layer made using Hydrofiber™ technology. Thanks to its absorbent properties and the use of silicone adhesives, the dressing is well suited for treating wounds of various etiologies.

It is composed of a waterproof, highly breathable polyurethane outer film, a soft absorbent foam layer, a Hydrofiber™ wound contact layer, and a gentle silicone adhesive (in the adhesive version).

The outer polyurethane layer makes the dressing waterproof, which protects the wound from viruses and bacteria, while allowing the patient to wash without removing the dressing.

Thanks to the outer polyurethane film, the wound environment maintains an optimal moisture level, with any excess moisture being evaporated.

The dressing absorbs and retains exudate in its structure, reducing the risk of skin maceration.

Hydrofiber™ technology also helps reduce the level of active matrix metalloproteinases in chronic wounds and stimulates angiogenesis, which greatly benefits the healing process. (AQUACEL FOAM).

Foam dressing

Dressing made of a three-layer construction consisting of:

a perforated wound-contact layer that allows even sticky exudate to pass into the dressing,

a hydrocellular core that absorbs and retains fluid in its microscopic structure,

a breathable outer surface that allows excess moisture to evaporate from the dressing, while serving as a tight barrier against bacteria and foreign matter.

This dressing is suitable for exudate absorption and for treating partial- or full-thickness
wounds.

Dressings should not be used with oxidising agents such as hypochlorite solutions or hydrogen peroxide, as these may break down the absorbent hydrocellular component of the dressing. (ALLEVYN).

Foam dressing with Safetac® soft silicone contact layer

It is soft and conformable to the surrounding skin

The dressing has a unique pain-minimising contact layer made of Safetac® soft silicone. Clinical studies show that dressings with Safetac® technology minimise wound and skin damage during removal. By sealing the wound edges, they help prevent maceration. Because they do not damage the wound or surrounding skin, pain during dressing changes is minimised. For shallow wounds with low to moderate exudate. (MEPILEX).

Foam dressing for low exudate wounds – 3-layer structure

The dressing consists of an outer polyurethane layer that is waterproof and provides effective protection against bacteria and viruses, while allowing optimal moisture evaporation from the wound environment. The middle layer is a thin, flexible, and soft foam that absorbs exudate and maintains a moist wound environment conducive to healing. The adhesive contact layer is made of silicone. The silicone layer is gentle and skin-friendly, allowing safe and painless application, removal, and repositioning.

Its soft and elastic design allows it to adapt effortlessly to different areas of the body. The dressing effectively protects, secures, and cares for low-exudate wounds. (Foam Lite™ ConvaTec).

Foam dressing with silicone – Kliniderm®

Soft, conformable, and absorbent polyurethane foam dressing with a silicone contact layer. This layer protects the surrounding skin and reduces pain during dressing changes. Exudate is retained inside the dressing, while the outer layer allows for free gas exchange.

Suitable for superficial wounds. (Kliniderm Foam Silicone).

Foam dressing with contact layer made using TLC technology

Contact dressing intended for clean wounds with slight exudate, especially during granulation and epithelialization stages. (UrgoTul Absorb).

Group 4. Foam dressings with antimicrobial substances

Polyurethane dressing containing 0.5% PHMB and 0.1% B-panthenol

The dressing consists of a polyurethane foam core with an open-cell structure. The foam core absorbs and retains exudate, reducing maceration of the surrounding skin. The antimicrobial agent PHMB (polyhexamethylene biguanide) reduces and prevents bacterial growth in the wound and dressing. B-Panthenol moisturises and improves skin hydration. The dressing also features a breathable outer polyurethane layer that allows internal moisture transfer while being resistant to external bacteria and water, thus maintaining a moist wound environment.

It can be used as a primary or secondary dressing. (KLINIDERM FOAM PHMB).

Antibacterial foam dressing with a Safetac® silicone contact layer

Antibacterial foam dressing for wounds with low to moderate exudate.

The dressing gently adheres to the skin thanks to the unique Safetac® silicone contact layer, which reduces pain. This significantly lessens the pain experienced by patients during dressing changes.

It exhibits rapid and long-lasting antibacterial activity.

In vitro studies have shown that the silver foam dressing can inactivate wound pathogens (bacteria and fungi) within 30 minutes. According to international consensus, antibacterial action is essential and key to reducing biological contamination in infected wounds. The dressing acts as an antibacterial barrier where there is a high risk of infection or reinfection. (Mepilex Ag).

Multilayer foam dressing with silver ions

The dressing is suitable for shallow wounds that are infected or suspected of infection, with moderate to heavy exudate.

The dressing can be used as either a primary or secondary dressing.

Thanks to the presence of silver ions, the dressing is effective against a wide range of microorganisms, including MRSA, VRE, and other antibiotic-resistant strains.

Thanks to Hydrofiber technology, the dressing can also be used on heavily exuding wounds. When in contact with wound exudate, the dressing’s contact layer transforms into a cohesive gel, allowing it to conform closely to the wound surface and fill empty spaces where bacteria might grow.

The dressing also supports the removal of necrotic tissue (autolytic debridement), without damaging healthy tissue. It also reduces the risk of cross-infection during dressing changes by retaining exudate and its harmful components within the dressing. (AQUACEL® Ag Foam).

Definition of a Medical Device according to the Medical Devices Act

According to Article 2(1) of the Polish Act of 7 April 2022 on Medical Devices (Journal of Laws 2022, item 974):

A medical device is a tool, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used on humans for medical purposes such as:

diagnosing, preventing, monitoring, treating or alleviating disease,

diagnosing, monitoring, treating, alleviating or compensating for injury or disability,

examining, replacing or modifying the anatomy or a physiological process,

controlling conception.

Additionally:

A medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means, but its function may be assisted by such means.

The differences between a medical device and a medicinal product

Definition and mechanism of action

A medical device works through mechanical, physical or electronic means – e.g., implants, syringes, diagnostic equipment, dressings. It may contain pharmacological substances, but these are not its main mechanism of action.

A medicinal product acts on the human body through pharmacological, immunological or metabolic means – e.g., antibiotics, vaccines, painkillers.

Regulations

Medical devices are governed by Regulation (EU) 2017/745 (MDR).

Medicinal products are regulated by the Pharmaceutical Law and Regulation (EU) 2001/83/EC.

Assessment and marketing authorization

Medical devices require a conformity assessment and CE certification, often involving a notified body.

Medicinal products must undergo clinical trials and receive marketing authorization from bodies such as the EMA (European Medicines Agency) or URPL (Polish Office for Registration of Medicinal Products).

In summary: a medical device is not a drug, although some products (e.g., inhalers with medication) may combine characteristics of both categories.

The definition of a biocidal product can be found in the Act of 9 October 2015 on Biocidal Products (Journal of Laws 2022, item 2178).

Definition of a biocidal product

According to Article 2(1)(1) of this Act:

A biocidal product is “a substance, mixture or article, in the form in which it is supplied to the user, consisting of, containing, or generating one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise control harmful organisms by means other than purely physical or mechanical action”.

This definition aligns with and implements Regulation (EU) 528/2012 into national law.

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