NCT07066254

The Mepilex Cesarean Delivery Trial

A Randomized Controlled Trial on the Effect of a Silver-impregnated Antimicrobial Foam Dressing on Surgical Site Infections After Cesarean Delivery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Surgical Site Infection Following Cesarean Delivery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-07-15
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study