Recruiting

Mepilex Border Post-Op Ag vs. Standard Dressing

Sponsor:

Montefiore Medical Center

Code:

NCT07914569

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mepilex Border Post-Op Ag

Standard Postoperative Dressing

Study Details

Brief summary:

The goal of this clinical trial is to learn whether a silver-containing foam dressing (Mepilex Border Post-Op Ag) works as well as the standard dressing in preventing surgical site infection after cesarean delivery. The main questions it aims to answer are:

Is the rate of surgical site infection with Mepilex Border Post-Op Ag no worse than with the standard dressing?

How do the two dressings compare for other wound problems, wound-related hospital or clinic visits, and patient satisfaction?

Researchers will compare participants who receive Mepilex Border Post-Op Ag with participants who receive the standard dressing.

Participants will:

1. Have their cesarean delivery as planned by their care team
2. Be randomly assigned to one of the two dressings, which is placed over the incision at the end of surgery
3. Complete a short questionnaire about their dressing
4. Receive a follow-up phone call about 30 to 40 days after delivery (POD 30-40) to check on their wound

Conditions

Surgical Site Infection

Study ID

NCT07914569

Start date

Nov 3, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 years or older
  • Undergoing scheduled cesarean delivery or unscheduled non-emergent cesarean delivery at Montefiore Medical Center - Weiler Hospital
  • Able to provide written informed consent
  • Access to a working telephone number for follow-up communication
  • Willingness to comply with study procedures and follow-up assessments

Exclusion Criteria:

  • Known hypersensitivity or allergy to silver, silicone, adhesive materials, Mepilex Border Post-Op Ag, or any dressing component
  • Active skin infection at the planned dressing site
  • Psoriasis, eczema, chronic dermatitis or other dermatological condition that may interfere with dressing application, wound assessment, or interpretation of study outcomes
  • Immunocompromised status, including current chemotherapy, chronic system corticosteroid use, or known HIV infection with CD4 count <200 cells/mm\^3
  • Participation in another interventional trial that may affect wound healing or postoperative outcomes
  • Intraoperative conversion to a vertical skin incision
  • Anticipated inability to complete follow-up because of relocation, incarceration, or other logistical barrier
  • Severe pain, acute distress, or other clinical circumstances at the time of study approach that, in the judgment of the physician member of the study team responsible for obtaining informed consent, make it inappropriate to initiate or complete the research informed consent process
  • Emergent cesarean delivery in which informed consent cannot reasonably be obtained prior to surgery and/or standard sterile skin preparation procedures are not utilized

Comment: Won't intraoperative conversion to a vertical incision not be known until the time of Sx?

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mepilex Border Post-Op Ag

Participants will receive a single Mepilex Border Post-Op Ag dressing applied over the cesarean incision immediately after skin closure in the operating room. The dressing is intended to remain in place until approximately postoperative day 7 (POD 7) unless earlier removal is clinically indicated or requested by the participant. If the dressing is removed early, it may be replaced at the treating physician's discretion.

active comparator: Standard Postoperative Dressing

Participants will receive the institution's standard postoperative cesarean dressing, applied over the incision immediately after skin closure in the operating room. The dressing is typically removed on POD 1 or POD 2 according to routine institutional practice.

Interventions

Mepilex Border Post-Op Ag

An FDA-cleared (510(k) K100029), self-adherent, silver-containing soft silicone foam dressing (Mölnlycke Health Care) indicated for postoperative wounds. Applied according to manufacturer labeling.

Standard Postoperative Dressing

A sterile Telfa non-adherent pad (Cardinal Health) covered with sterile gauze and secured with a Primapore adhesive dressing (Smith \& Nephew). This is the institution's routine postoperative cesarean dressing.

Primary outcome measure

  • Number of participants with surgical site infection (SSI) within 30 days of cesarean delivery [ Time Frame: Up to 30 days after cesarean delivery ]

Central Contacts and Locations

Central contacts

Anna Weinstein, DO

347-543-3542anweinstei@montefiore.org

Locations

Montefiore-Einstein Jack D. Weiler Hospital

Recruiting

The Bronx, New York, United States, 10461

Contacts

Anna Weinstein, DO

347-543-3542anweinstei@montefiore.org

Principal Investigator:

Lilly Liu, MD, MPH

More Information

Sponsor

Montefiore Medical Center

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Cesarean Delivery
  • Surgical Site Infection
  • Postoperative Complications
  • Cesarean Section
  • Pregnant Women
  • Wound Dressing
  • Patient satisfaction
  • Occlusive Dressings
  • Infection Control
  • Silver antimicrobial foam
  • Mepilex Border Post-Op Ag

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.