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The Mepilex Cesarean Delivery Trial / MEPIDEL
A Randomized Controlled Non-Inferiority Trial of Mepilex Border Post-Op Ag Versus Standard Postoperative Dressing Following Cesarean Delivery
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Age 18 years or older * Undergoing scheduled cesarean delivery or unscheduled non-emergent cesarean delivery at Montefiore Medical Center - Weiler Hospital * Able to provide written informed consent * Access to a working telephone number for follow-up communication * Willingness to comply with study procedures and follow-up assessments Exclusion Criteria: * Known hypersensitivity or allergy to silver, silicone, adhesive materials, Mepilex Border Post-Op Ag, or any dressing component * Active skin infection at the planned dressing site * Psoriasis, eczema, chronic dermatitis or other dermatological condition that may interfere with dressing application, wound assessment, or interpretation of study outcomes * Immunocompromised status, including current chemotherapy, chronic system corticosteroid use, or known HIV infection with CD4 count \<200 cells/mm\^3 * Participation in another interventional trial that may affect wound healing or postoperative outcomes * Intraoperative conversion to a vertical skin incision * Anticipated inability to complete follow-up because of relocation, incarceration, or other logistical barrier * Severe pain, acute distress, or other clinical circumstances at the time of study approach that, in the judgment of the physician member of the study team responsible for obtaining informed consent, make it inappropriate to initiate or complete the research informed consent process * Emergent cesarean delivery in which informed consent cannot reasonably be obtained prior to surgery and/or standard sterile skin preparation procedures are not utilized Comment: Won't intraoperative conversion to a vertical incision not be known until the time of Sx?
About the study
The goal of this clinical trial is to learn whether a silver-containing foam dressing (Mepilex Border Post-Op Ag) works as well as the standard dressing in preventing surgical site infection after cesarean delivery. The main questions it aims to answer are:
Is the rate of surgical site infection with Mepilex Border Post-Op Ag no worse than with the standard dressing?
How do the two dressings compare for other wound problems, wound-related hospital or clinic visits, and patient satisfaction?
Researchers will compare participants who receive Mepilex Border Post-Op Ag with participants who receive the standard dressing.
Participants will:
1. Have their cesarean delivery as planned by their care team 2. Be randomly assigned to one of the two dressings, which is placed over the incision at the end of surgery 3. Complete a short questionnaire about their dressing 4. Receive a follow-up phone call about 30 to 40 days after delivery (POD 30-40) to check on their wound
What is being tested
- Mepilex Border Post-Op Ag (device)
- Standard Postoperative Dressing (device)
Sponsor: Montefiore Medical Center · Participants: 240 · Started: Nov 3, 2026
Contact the study team
- Anna Weinstein, DO · Phone: 347-543-3542
Official record on ClinicalTrials.gov — NCT07914569
Locations in the U.S.
| New York | Montefiore-Einstein Jack D. Weiler Hospital, The Bronx |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.