The Mepilex Cesarean Delivery Trial

Not Applicable

Not yet recruiting

• Conditions: Surgical Site Infection Following Cesarean Delivery

• Registration Number: NCT07066254
• Lead Sponsor: Montefiore Medical Center

Brief 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 a common complication following cesarean delivery and are associated with increased maternal morbidity, prolonged recovery, 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-09-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 480

Inclusion Criteria

• Age 18 years or older
• Undergoing non-emergent cesarean delivery at our institution
• 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, Aquacel Ag, or adhesive materials
• Presence of active skin infection or open skin condition at the planned dressing site
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery	Within 30 days of cesarean delivery/wound dressing application	The primary outcome is the occurrence of a surgical site infection (SSI) within 30 days following cesarean delivery, as defined by the Centers for Disease Control and Prevention (CDC) criteria. Occurrences of SSIs include superficial incisional, deep incisional, or organ/space infections related to the surgical incision. Diagnosis will be determined through inpatient clinical monitoring, review of electronic health records for any related outpatient or emergency department visits, and follow-up telephone assessment conducted 30 days after cesarean delivery. SSIs will be summarized by study arm using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
The Occurrence of Wound Seroma Formation	Within 30 days of cesarean delivery/wound dressing application	Presence of a wound seroma at the surgical site, identified through documentation in the medical record within the 30 day postoperative period, will be summarized by study arm using basic descriptive statistics.
The Occurrence of Wound Hematoma Formation	Within 30 days of cesarean delivery/wound dressing application	Presence of a wound hematoma at the surgical site, identified through documentation in the medical record within the 30-day postoperative period, will be summarized by study arm using basic descriptive statistics.
The Occurrence of Wound Dehiscence	Within 30 days of cesarean delivery/wound dressing application	Presence of partial or complete wound dehiscence at the surgical site, identified through documentation in the medical record within the 30-day postoperative period, will be summarized by study arm using basic descriptive statistics.
Unscheduled Postoperative Healthcare Visits Related to Wound Concerns	Within 30 days of cesarean delivery/wound dressing application	The number of unscheduled patient visits (either emergency department or outpatient clinic) related to wound complications, including concerns about drainage, infection, dehiscence, or dressing problems will be summarized by study arm using basic descriptive statistics.
Readmission due to Wound Complications	Within 30 days of cesarean delivery/wound dressing application	Hospital readmission events occurring within 30 days postoperatively that are attributable to wound-related issues, including surgical site infection or wound breakdown will be summarized by study arm using basic descriptive statistics.
Reoperation due to Wound Complications	Within 30 days of cesarean delivery/wound dressing application	The occurrence of a return to the operating room for a wound-related complication (e.g., infection, dehiscence, hematoma evacuation) within the 30-day postoperative period, as documented in the medical record, will be summarized by study arm using basic descriptive statistics.
Patient Satisfaction With Postoperative Dressing	At time of dressing removal, up to 7 days after cesarean delivery	Patient satisfaction will be assessed using the Adapted Wound Dressing Satisfaction Questionnaire (WDSQ), a 9-item instrument that evaluates comfort, ease of movement, perceived wound protection, dressing appearance, and skin irritation. Responses to the first 8 questions are rated on a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The final item is rated on an 11-point Likert scale, ranging from 0 (Not at all satisfied) to 10 (Extremely satisfied), for an overall possible scoring range of 8-50, wherein higher scores are associated with increased global satisfaction with the assigned dressing.

Trial Locations

Locations (1)

Jack D. Weiler Hospital (Einstein Campus); 🇺🇸 Bronx, New York, United States