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The Mepilex Cesarean Delivery Trial

NCT07066254 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-04-21

No results posted yet for this study

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

Conditions

  • Surgical Site Infection Following Cesarean Delivery

Interventions

DEVICE

Mepilex Ag Dressing

A silver-impregnated antimicrobial foam dressing (Mepilex Ag) will be placed over the cesarean incision immediately following skin closure in the operating room. Participants assigned to this intervention will be instructed to leave the dressing in place for 7 days, in accordance with manufacturer guidelines, unless earlier removal is necessary due to dressing saturation, displacement, or clinical concern. Mepilex Ag is FDA-cleared for use as a wound dressing and is designed to maintain a moist wound environment while providing sustained antimicrobial protection to help reduce the risk of surgical site infection.

DEVICE

Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)

A standard postoperative dressing consisting of a sterile Telfa non-adhesive pad placed over the cesarean incision, covered with gauze, and secured with a Primapore adhesive bandage. The dressing is applied immediately following skin closure in the operating room as part of routine institutional care. It is typically removed within 24 to 48 hours postoperatively, depending on wound condition and provider discretion.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Georgios Doulaveris · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066254 on ClinicalTrials.gov