ClinicalTrials.gov
ClinicalTrials.gov Menu

Healing Nipple Wounds: Comparison Between 2 Treatment Modalities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03389516
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Dr. Jinna Weissman
Information provided by (Responsible Party):
Dr. Meir Weisbrod, Laniado Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Nipple Wounds Other: Polymem Other: Lanolin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healing Nipple Wounds: Comparison Between 2 Treatment Modalities: Lanolin Ointmentnad Nursicare Therapeutic Breast Pads Among Postpartum Mothers Dealing With Sore Nipples
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lanolin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Polymem breast pads Other: Polymem
wound care dressings
Other Name: Nursicare
Active Comparator: Lanolin Other: Lanolin
wound care oinment
Other Name: Lansinoh



Primary Outcome Measures :
  1. Pain reduction [ Time Frame: • 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 ]

    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?

  2. Wound improvement [ Time Frame: • 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) ]
    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.


Secondary Outcome Measures :
  1. Transition to full breastfeeding [ Time Frame: • 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 ]

    This measurement will be filled in the questioner:

    How do you feed your baby today?

    1. Breastfeeding only
    2. Breastfeeding combined with something else

  2. Product satisfaction [ Time Frame: At follow up by phone calls on days: 14 and 30. ]

    This measurement will be filled in the questioner:

    Were you satisfied with the use of Nursicare®/Lanolin as a treatment to your nipple pain?

    1. Very satisfied
    2. Satisfied
    3. Moderately satisfied
    4. Not satisfied
    5. Not satisfied at all
    6. It didn't affect me

  3. Ease of use [ Time Frame: At follow up by phone calls on days: 14 and 30. ]

    This measurement will be filled in the questioner:

    How did you find Nursicare® pads/Lanolin convenient to use?

    1. Very convenient
    2. Convenient
    3. Not convenient
    4. Not convenient at all

  4. Recommendation to others [ Time Frame: At follow up by phone calls on days: 14 and 30. ]

    This measurement will be filled in the questioner:

    Will you recommend your breastfeeding friends toy use Nursicare®/Lanolin in case they have nipple pain?

    1. Definitely yes
    2. Probably yes
    3. I'm not sure
    4. Probably not
    5. Definitely not

  5. The response for future use if necessary [ Time Frame: At follow up by phone calls on days: 14 and 30. ]

    This measurement will be filled in the questioner:

    In case you have another wound in the future, will you use Nursicare®/Lanolin again to treat the pain?

    1. Definitely yes
    2. Probably yes
    3. I'm not sure
    4. Probably not
    5. Definitely not



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Postpartum breastfeeding mothers for healthy babies, who will meet the following inclusion criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389516


Contacts
Contact: Adi Kliffer +972-9-860-4651 adikliffer@hotmail.com
Contact: Alona Burla +972-9-860-4651 alona1105@gmail.com

Locations
Israel
Laniado Hospital, The Betty Retter Mother & Baby Medical Center Not yet recruiting
Netanya, Israel
Contact: Weisbrod, Dr.    972-9-8604601      
Sponsors and Collaborators
Laniado Hospital
Dr. Jinna Weissman

Responsible Party: Dr. Meir Weisbrod, Director of Neonatal Department, Laniado Hospital
ClinicalTrials.gov Identifier: NCT03389516     History of Changes
Other Study ID Numbers: 0142-16-LND
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries