Healing Nipple Wounds: Comparison Between 2 Treatment Modalities

Summary

It is widely accepted that breast milk is the optimal source of infant nutrition. Despite the World Health Organization (WHO) recommendation of exclusive breastfeeding for the first 6 months of infant life, many women discontinue breastfeeding as a result of perceived difficulties. In Israel, 88.4% of mothers declare about their intentions to breastfeed. Only 70.9% are still breastfeeding 2 months postpartum. Nipple pain is a highly prevalent, significant reason for breastfeeding cessation.

In the past, we encouraged wound healing nipples by drying (air drying; sun; other heat source). It turned out that this drying only delays the healing due to lack of moisture, causing cracks in the outer layer of the nipple. Today, nipple wound care needs treatment approaches consistent with wounds treatment in other body parts (moist wound healing), and which also addresses reduction of pain. Studies have shown that the preservation of moisture accelerates healing and allows epithelization.

In the past couple of years, the Nursicare therapeutic breastfeeding pads have become a commonly used option for sore nipples. Nursicare pads enhance moist wound healing and soothe traumatized tissues, localize the inflammation, reducing wound pain and providing comfort at the wound site. This solution seems to be more efficient, and pads can be removed with virtually no pain and no remnants on the nipple that might cause concerns for allergic reaction for the infant.

In this clinical trial we attempt to compare between the 2 treatments: Lanolin ointment and Nursicare therapeutic breast pads among postpartum mothers dealing with sore nipples and to examine the effectiveness of each treatment for short term (period till primary pain relief) and long term (total period for wound closure).

Study hypothesis is that Nursicare provides better pain relief and faster healing that Lanolin.

Method The trial will include postpartum mothers in Laniado Hospital in Natanya and mother from "Halav M" breastfeeding clinic in Olesh, Israel who had complained of nipple pain with any sign of nipple trauma to one or both nipples.

The participants will be randomly selected to each group:

1. Treatment with the Nursicare therapeutic breastfeeding pads.
2. Treatment with application of Lanolin. A total number of participants: At least 50 mothers randomly chosen to each group will be recruited for this trial (p). Randomization will be based on natural arrival sequence - where every other mother will be placed on 'Nursicare group' and the alternate every other mother will be placed in 'control/Lanoline group). The only exception for this is when a certain treatment is already started - in those cases the patient will continue that treatment and compensation will be done to the sequence of allocation process.

Conditions

• Nipple Wounds

Interventions

OTHER

Polymem

wound care dressings

OTHER

Lanolin

wound care oinment

Sponsors & Collaborators

• Dr. Jinna Weissman

  collaborator UNKNOWN

• Laniado Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-31

Primary Completion

2019-12-31

Completion

2020-06-30

Countries

• Israel

Study Locations