Overview
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:
- Have their cesarean delivery as planned by their care team
- Be randomly assigned to one of the two dressings, which is placed over the incision at the end of surgery
- Complete a short questionnaire about their dressing
- Receive a follow-up phone call about 30 to 40 days after delivery (POD 30-40) to check on their wound
Description
Surgical site infection (SSI) is one of the most common complications of cesarean delivery and can lead to added treatment, longer hospital stays, readmission, and additional procedures. Risk is higher in patients with obesity, diabetes, prolonged rupture of membranes, intraamniotic infection, or a prior cesarean delivery. Many of these risk factors are common in the patient population served by the study site, where SSI rates approaching 10% after cesarean delivery have been observed.
The postoperative dressing is a potentially modifiable part of surgical care. Standard cesarean dressings provide a physical barrier over the incision but have no antimicrobial properties and offer limited moisture or drainage control. Silver-containing dressings have been studied in several surgical fields because of the antimicrobial properties of ionic silver. However, silver dressings vary widely in design. A prior randomized trial of a silver nylon mesh dressing after cesarean delivery found no reduction in SSI compared with standard care. That dressing differs substantially from multilayer silver foam dressings with silicone adhesive, such as Mepilex Border Post-Op Ag, so its findings may not apply to foam-based products.
Mepilex Border Post-Op Ag is FDA-cleared and already used in routine clinical practice at the study institution, but prospective data on its performance after cesarean delivery are limited, particularly in higher-risk obstetric populations. Before broader use can be supported, it is important to confirm that wound outcomes are not worse than with the standard dressing. This study therefore uses a non-inferiority design. An increase in SSI of more than 5 percentage points was judged clinically unacceptable, based on clinical judgment, published cesarean SSI data, and expected baseline infection rates at the study site. If non-inferiority is shown, secondary analyses will examine whether the foam dressing offers additional benefit.
Patient experience is also an important part of postoperative recovery. Comfort, mobility, confidence in wound protection, and ease of dressing care may differ between dressings, so participant-reported satisfaction is collected alongside clinical wound outcomes.
Eligibility
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?
