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NOT YET RECRUITING
NCT07914569
NA

The Mepilex Cesarean Delivery Trial / MEPIDEL

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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

Official title: A Randomized Controlled Non-Inferiority Trial of Mepilex Border Post-Op Ag Versus Standard Postoperative Dressing Following Cesarean Delivery

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-11

Completion Date

2027-11

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

DEVICE

Mepilex Border Post-Op Ag

An FDA-cleared (510(k) K100029), self-adherent, silver-containing soft silicone foam dressing (Mölnlycke Health Care) indicated for postoperative wounds. Applied according to manufacturer labeling.

DEVICE

Standard Postoperative Dressing

A sterile Telfa non-adherent pad (Cardinal Health) covered with sterile gauze and secured with a Primapore adhesive dressing (Smith \& Nephew). This is the institution's routine postoperative cesarean dressing.

Locations (1)

Montefiore-Einstein Jack D. Weiler Hospital

The Bronx, New York, United States