Status:
UNKNOWN
Healing Nipple Wounds: Comparison Between 2 Treatment Modalities
Lead Sponsor:
Laniado Hospital
Collaborating Sponsors:
Dr. Jinna Weissman
Conditions:
Nipple Wounds
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03389516
Start Date
January 1 2018
End Date
June 1 2020
Last Update
January 3 2018
Active Locations (1)
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1
Laniado Hospital, The Betty Retter Mother & Baby Medical Center
Netanya, Israel