Mepilex Ag Dressing for Postpartum Infection

(MEPIDEL Trial)

Overseen By Anna Weinstein

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Chemotherapy, Steroids

Disqualifiers: Silver allergy, Skin infection, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period

480 Participants Needed

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 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 Is on the Research Team?

Georgios Doulaveris

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for patients undergoing cesarean delivery. It's designed to see if a special foam dressing with silver (Mepilex Ag) can prevent infections better than standard dressings after surgery.

Inclusion Criteria

Undergoing non-emergent cesarean delivery at our institution

I am 18 years old or older.

I can give my consent in English or Spanish.

Exclusion Criteria

Known hypersensitivity or allergy to silver, Aquacel Ag, or adhesive materials

I am not in any other trials that could affect wound healing or surgery results.

Inability to complete follow-up due to anticipated relocation, incarceration, or other logistical barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery and receive either a silver-impregnated antimicrobial foam dressing or a standard dressing

Immediate postoperative period

1 visit (in-person)

Follow-up

Participants are monitored for wound complications and signs of infection during the postpartum period

30 days

Follow-up telephone assessment and review of electronic health records

Patient Satisfaction Assessment

Patient satisfaction with the postoperative dressing is assessed using the Adapted Wound Dressing Satisfaction Questionnaire

Up to 7 days after cesarean delivery

What Are the Treatments Tested in This Trial?

Interventions

• Mepilex Ag

Trial Overview The study compares the effectiveness of Mepilex Ag, a silver-containing antimicrobial foam dressing, against standard surgical dressings in preventing post-cesarean wound infections. Participants are randomly assigned to one of the two dressing types.

How Is the Trial Designed?

Group I: Mepilex Ag Dressing Experimental Treatment 1 Intervention

Participants in this arm will receive a silver-impregnated antimicrobial foam dressing (Mepilex Ag) applied to the surgical incision following cesarean delivery.

Group II: Standard Surgical Dressing (Telfa non-adhesive pad, gauze, Primapore adhesive bandage) Active Control 1 Intervention

Participants in this arm will receive the standard postoperative surgical dressing currently used at our institution following cesarean delivery. This dressing consists of a Telfa non-adhesive pad placed over the incision, covered with gauze, and secured with a Primapore adhesive bandage.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+