NCT07914569 The Mepilex Cesarean Delivery Trial / MEPIDEL
| NCT ID | NCT07914569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-11-03 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2026-11-03 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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?
Contact & Investigator
Lilly Liu, MD, MPH
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT07914569 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07914569 currently recruiting?
Yes, NCT07914569 is actively recruiting participants. Contact the research team at anweinstei@montefiore.org for enrollment information.
Where is the NCT07914569 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07914569 clinical trial?
NCT07914569 is sponsored by Montefiore Medical Center. The principal investigator is Lilly Liu, MD, MPH at Montefiore Medical Center. The trial plans to enroll 240 participants.