Proposed superiority study framework was not approved by the IRB. Study will be redeveloped as a non-inferiority study and resubmitted to the IRB.

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

Surgical site infections (SSIs) are among the most common complication following cesarean delivery and are associated with increased maternal morbidity, prolonged hospital stays, 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.

Inclusion Criteria:

• Age 18 years or older
• Undergoing non-emergent cesarean delivery at Montefiore-Einstein
• 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, Mepilex Ag, or adhesive materials
• Presence of active skin infection or open skin condition at the planned dressing site
• Psoriasis, eczema, or other acute or chronic dermatitis or skin condition that might affect the choice of optimal dressing or the results of the study
• 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

De-identified individual participant data (IPD) to be shared will include all data that underlie the results reported in any publication arising from the trial. This includes demographic and clinical characteristics, intraoperative details, incidence of surgical site infections and other wound complications, and patient-reported outcomes from the wound dressing satisfaction questionnaire. No personal identifiers will be shared.

IPD will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.

Qualified researchers affiliated with academic or healthcare institutions may request access to de-identified individual participant data (IPD) and supporting documentation for purposes of secondary analysis or meta-analysis. Requests must include a brief research proposal outlining study aims, methodology, and intended use of the data. Proposals will be reviewed by the study principal investigator and institutional research committee for scientific merit, ethical compliance, and consistency with the informed consent provided to participants. Approved users must sign a data use agreement. Requests and documentation can be submitted via email to the study PI or designated contact at Montefiore Medical Center.