The Mepilex Cesarean Delivery Trial (MEPIDEL)

Montefiore Medicine Academic Health System

Status: Not yet enrolling

Conditions: Surgical Site Infection Following Cesarean Delivery

Treatments: Device: Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage); Device: Mepilex Ag Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07066254

2025-16900

Details and patient eligibility

About

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

Full description

Surgical site infections (SSIs) are among the most common complication following cesarean delivery and are associated with increased maternal morbidity, prolonged hospital stays, and higher healthcare costs. Despite the use of prophylactic antibiotics and standard perioperative practices, the risk of postoperative wound infection remains significant, especially in patients with additional risk factors such as obesity or diabetes.

Mepilex Ag is a silver-impregnated antimicrobial foam dressing that has antimicrobial properties and has been shown in other surgical populations to reduce the incidence of SSIs. It is FDA-cleared for use as a wound dressing but has not been specifically studied in the obstetrics population.

The overarching aim of this study is to assess whether the application of a silver-impregnated antimicrobial foam dressing at the time of cesarean delivery reduces the incidence of postoperative wound infections and improves related outcomes compared to standard surgical dressings. This randomized controlled trial will enroll eligible pregnant individuals undergoing cesarean delivery and randomly assign them to receive either the silver dressing or standard care dressing.

Study procedures and follow-up have been designed to systematically capture data related to postoperative wound outcomes, healthcare utilization, and patient experience. These data will support evaluation of the primary and secondary objectives and inform clinical practice regarding optimal strategies for wound management in this population.

This study aims to provide evidence to guide postoperative wound management after cesarean delivery.

Enrollment: 480 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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

Mepilex Ag Dressing

Experimental group

Description:

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

Treatment:

Device: Mepilex Ag Dressing