The Mepilex Cesarean Delivery Trial

Conditions

• Surgical Site Infection Following Cesarean Delivery

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Mepilex Ag Dressing — 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.
• Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage) — 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.

Study Details

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

Key Dates

Start date

Apr 30, 2026

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

480 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery [ Time Frame: Within 30 days of cesarean delivery/wound dressing application ]

Central Contacts

• Anna Weinstein
  3475433542
  [email protected]

Locations (1)

Find similar trials in The Bronx, NY