Healing Nipple Wounds: Comparison Between 2 Treatment Modalities

NCT03389516 | Unknown Phase 4

• 1 other identifier: 0142-16-LND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Treatment with the Nursicare therapeutic breastfeeding pads.
2. 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

Outcome Measures

Primary Outcomes (2)

• Pain reduction

  VAS scale will be used at several time points in order to assess the duration of pain reduction: 1. VAS scale ruler by the mother - if zero represents no pain and ten represents the worst pain imaginable, what number best describes the pain you have? 2. VAS scale ruler by the tester - If zero represents no pain and ten represents the worst pain imaginable, what number best describes the pain you think the mother has?

  • zero point • 30 minutes after applying the treatment • 4-6 hours after applying the treatment • 24 hours after applying the treatment • 3 days after applying the treatment • 6 days after applying the treatment

• Wound improvement

  measurement of the percentage of wounds closed at each measure point. We will calculate the surface of the wound using an application for calculating area or with a disposable tape measure from paper.

  • zero point • 3 days after applying the treatment • 6 days after applying the treatment (only in case the meeting will take place, according to the decision taken on day 3)

Secondary Outcomes (5)

• Transition to full breastfeeding

  • zero point • 30 minutes after applying the treatment • 4-6 hours after applying the treatment • 24 hours after applying the treatment • 3 days after applying the treatment • 6 days after applying the treatment

• Product satisfaction

  At follow up by phone calls on days: 14 and 30.

• Ease of use

  At follow up by phone calls on days: 14 and 30.

• Recommendation to others

  At follow up by phone calls on days: 14 and 30.

• The response for future use if necessary

  At follow up by phone calls on days: 14 and 30.

Study Arms (2)

Polymem breast pads

ACTIVE COMPARATOR

Other: Polymem

Lanolin

ACTIVE COMPARATOR

Other: Lanolin

Interventions

Polymem OTHER

wound care dressings

Also known as: Nursicare

Polymem breast pads

Lanolin OTHER

wound care oinment

Also known as: Lansinoh

Lanolin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling caused by breastfeeding or pumping.

You may not qualify if:

• Mothers having the following will be excluded from the study:
• Mothers with diabetes (it is known that diabetes impacts on wound healing and to avoid any credibility questions linked to this it is considered prudent to leave mothers with diagnosed diabetes out of the study)
• Mothers with skin allergies or taking medications for skin allergies
• Psychiatric patients who cannot give consent
• Mothers with grade IV nipple sores
• Mothers with skin diseases:
• thrush
• Stephen Johnson Disease
• Psoriasis
• Pampigos
• Mothers who will not undergo the full clinical follow-up program and will not arrive for at least one follow-up meeting will be excluded from the study.

Sponsors & Collaborators

• Laniado Hospital: lead
• Dr. Jinna Weissman: collaborator

Study Sites (1)

Laniado Hospital, The Betty Retter Mother & Baby Medical Center

Netanya, Israel

Location

MeSH Terms

Interventions

Polymem; Lanolin

Intervention Hierarchy (Ancestors)

Waxes; Lipids

Central Study Contacts

Adi Kliffer

CONTACT

+972-9-860-4651; adikliffer@hotmail.com

Alona Burla

CONTACT

+972-9-860-4651; alona1105@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neonatal Department

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)