The Mepilex Cesarean Delivery Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Surgical Site Infection Following Cesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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.

Mepilex Ag Dressing

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

Group Type EXPERIMENTAL

Mepilex Ag Dressing

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Mepilex Mepilex Ag silver-impregnated antimicrobial foam Telfa Primapore adhesive bandage standard dressing unmedicated dressing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes