Previous studies have shown that application of hyaluronic acid preparations to wounds of the skin and mucosa have a beneficial effect.
There is a lack of studies showing the effect of applying hyaluronic acid preparations to treat damaged nipple skin in breastfeeding mothers.
This study aims to determine the effect of applying a hyaluronic acid preparation to damaged nipple skin in breastfeeding women.
for mothers: a breastfeeding mother, living or residing in Osijek, with nipple skin damage (NTS 1, 2, 3, 4, or 5).
for babies: newborns from a singleton pregnancy, of gestational age from 37 to 42 weeks, with a birth weight of 2,500 to 4,500 grams.
for mothers: mothers who do not breastfeed, mothers not living or residing in Osijek, mothers without nipple skin damage and mothers using other preparations for healing sore nipples (shells, pads).
for children: visible anomalies in the newborn which may affect the breastfeeding process, newborns that required admission to the neonatal unit
Parallel
Treatment of damaged nipple skin: Preparation with hyaluronic acid
DrugThe active preparation will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.
Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid
DrugThe neutral preparation, containing only white vaseline, will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.
Healing of damaged nipples
Nipple healing will be measured using the Nipple Trauma Score (NTS). Measurements will be performed by the lead researcher using the following scale: 0) no macroscopically visible skin changes; 1) erythema or edema or combination of both; 2) superficial damage with or without scab formation of less than 25% of the nipple surface; 3) superficial damage with or without scab formation of more than 25% of the nipple surface; 4) partial-thickness wound with or without scab formation of less than 25% of the nipple surface; 5) partial-thickness wound with or without scab formation of more than 25% of the nipple surface.
Level of nipple pain
Nipple pain will be estimated using an adapted VAS.The pain scale is marked by numbers 0 to 10, where 0 means no pain, and 10 is the highest pain imaginable. The mother will decide on the VAS scale, which measure best fits her pain: 0) no pain, feeling that the child is moving my breast; 1-2) minimal discomfort and pain; 3-5) moderate pain; 6-8) severe pain; 9-10) the severest pain I can imagine.
Mother's satisfaction with allocated treatment
The mother's satisfaction with the applied preparation will be measured using a Likert scale. The mother will be able to choose one of the following options: 1- Very dissatisfied; 2 - Dissatisfied; 3 - Neutral/ don't have an opinion; 4 - Satisfied; and 5 - Very satisfied.
Exclusive breastfeeding rates at days 3, 7, 10, and 30 postpartum.
During the Breastfeeding Support Unit visits, mothers wiil be asked by the lead researcher how their newborn was fed in the previous 24h, and since the last visit. WHO breastfeeding definitions wiil be used, according to which exclusive breastfeeding is defined as receiving only human milk, without any other fluids or food, apart from minerals and vitamins.
Side effects in mother and child
During Breastfeeding Support Unit visits, mothers will be asked whether they have noticed any side effects on themselves or on their infants.
Click on the lead sponsor to view all of their trials.
