WithdrawnNot Applicable

The Mepilex Cesarean Delivery 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.

0Started 2026-04

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Undergoing non-emergent cesarean delivery at Montefiore-Einstein * Able to provide informed consent in English or Spanish * Has a working telephone number for follow-up communication Exclusion Criteria: * Known hypersensitivity or allergy to silver, Mepilex Ag, or adhesive materials * Presence of active skin infection or open skin condition at the planned dressing site * Psoriasis, eczema, or other acute or chronic dermatitis or skin condition that might affect the choice of optimal dressing or the results of the study * Participation in another interventional trial affecting wound healing or surgical outcomes * Immunocompromised status (e.g., current chemotherapy, chronic steroid use, or known HIV with CD4 \<200) * Intraoperative conversion to vertical skin incision or other nonstandard approach * Inability to complete follow-up due to anticipated relocation, incarceration, or other logistical barrier

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1I saw a trial called the Mepilex Cesarean Delivery Trial that was studying whether a specific wound dressing could reduce infection rates after C-sections, but it shows as withdrawn — can you tell me why it was withdrawn and whether that affects how we should think about wound care after my procedure?
2Since this trial was withdrawn before completing, is there other existing evidence about specialized post-cesarean wound dressings like Mepilex that you already use to guide your practice?
3Given that surgical site infection within 30 days after a C-section is a real concern, what wound care approaches do you currently recommend for patients like me, and are there other active studies I could be considered for?
4Are there standard-of-care strategies — like specific dressing types, antibiotic protocols, or wound monitoring plans — that you would put in place for me regardless of any trial, especially if I have factors that might raise my infection risk?
5Since this trial never finished and didn't produce results, how should I weigh the lack of completed data when thinking about my own post-cesarean wound care decisions?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery

Timeframe: Within 30 days of cesarean delivery/wound dressing application

Trial details

NCT IDNCT07066254

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Surgical Site Infection Following Cesarean Delivery trials