RecruitingPhase 4NCT05591651

Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women

The Effectiveness of Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women: a Double-blind Randomised, Controlled Trial

Sponsor

Specijalisticka Pedijatrijska Ordinacija prim.mr.sc. Maja Stimac, Specijalist Pedijatrije Sspecijalnosti Neonatologije

Enrollment

160 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

Breastfeeding Cracked Nipple Healing Wound

Summary

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study tests whether a hyaluronic acid cream can help heal damaged or sore nipples in breastfeeding mothers faster than standard care, making it easier for mothers to continue breastfeeding comfortably. You may be eligible if (mother): - You are a breastfeeding mother living or residing in Osijek - You have nipple skin damage (rated at any level on the nipple trauma scale) You may be eligible if (baby): - Your baby was born at 37 to 42 weeks of gestation - Your baby has a birth weight between 2,500 and 4,500 grams - Your baby was born from a singleton pregnancy You may NOT be eligible if (mother): - You are not currently breastfeeding - You do not live in Osijek - You do not have nipple skin damage - You are already using other nipple healing products (shells, pads, or other preparations) You may NOT be eligible if (baby): - Your baby has visible birth anomalies that affect breastfeeding - Your baby was admitted to the neonatal intensive care unit Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreatment of damaged nipple skin: Preparation with hyaluronic acid

The 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.

DRUGTreatment of damaged nipple skin: Neutral preparation without hyaluronic acid

The 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.