Clinical Trial

The Mepilex Cesarean Delivery Trial

Study acronym: MEPIDEL
Withdrawn
View on ClinicalTrials.gov →
Why the trial stopped
Proposed superiority study framework was not approved by the IRB. Study will be redeveloped as a non-inferiority study and resubmitted to the IRB.
Summary
The goal of this clinical trial is to learn whether using a silver-containing antimicrobial foam dressing (Mepilex Ag) can help prevent surgical site infections in patients undergoing cesarean delivery. The main questions it aims to answer are: 1. Does Mepilex Ag reduce the rate of surgical site infections after cesarean delivery? 2. Is Mepilex Ag more effective than standard wound dressings in preventing infection? Researchers will compare those who receive the Mepilex Ag dressing to those who receive the standard dressing to see if the silver impregnated antimicrobial foam dressing lowers infection rate. Participants will: 1. Undergo a routine cesarean delivery as per usual obstetric indication 2. Be randomly assigned to receive either a silver-containing foam dressing or a standard dressing after surgery 3. Be monitored for wound complications and signs of infection during the postpartum period
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-06-19
notable Enrollment reduced: 480 -> 0 participants 2026-06-19
notable Primary completion pushed: 2026-12 -> 2027-02 2026-04-22
minor Completion pushed: 2026-12 -> 2027-02 2026-04-22
Trial Details
NCT Number NCT07066254
Lead Sponsor Montefiore Medical Center
Conditions Surgical Site Infection Following Cesarean Delivery
Start Date 2026-04
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-18