Mepilex Dressing for Surgical Site Infection

(MEPIDEL Trial)

AW
LL
Overseen ByLilly Liu
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

LL

Lilly Liu, MD, MPH

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for people having a planned cesarean delivery. Participants must be able to have either type of wound dressing placed after surgery and complete follow-up checks.

Inclusion Criteria

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
See 2 more

Exclusion Criteria

Known hypersensitivity or allergy to silver, silicone, adhesive materials, Mepilex Border Post-Op Ag, or any dressing component
Participation in another interventional trial that may affect wound healing or postoperative outcomes
Anticipated inability to complete follow-up because of relocation, incarceration, or other logistical barrier
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Mepilex Border Post-Op Ag
  • Standard Postoperative Dressing

Trial Overview

The study compares two types of dressings used after C-section: a silver-containing foam dressing (Mepilex Border Post-Op Ag) versus the standard postoperative dressing, assigned randomly. Researchers will look at infection rates, wound problems, and patient satisfaction.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mepilex Border Post-Op AgExperimental Treatment1 Intervention
Group II: Standard Postoperative DressingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+