A Randomized Controlled Trial on the Effect of a Silver-impregnated Antimicrobial Foam Dressing on Surgical Site Infections After Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Montefiore Medical Center
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery
Study Overview
Brief Summary
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:
- Does Mepilex Ag reduce the rate of surgical site infections after cesarean delivery?
- 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:
- Undergo a routine cesarean delivery as per usual obstetric indication
- Be randomly assigned to receive either a silver-containing foam dressing or a standard dressing after surgery
- Be monitored for wound complications and signs of infection during the postpartum period
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage) (Device)
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.
Intervention: Mepilex Ag Dressing (Device)
Outcomes
Primary Outcomes
Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery
Time Frame: Within 30 days of cesarean delivery/wound dressing application
The primary outcome is the occurrence of a surgical site infection (SSI) within 30 days following cesarean delivery, as defined by the Centers for Disease Control and Prevention (CDC) criteria. Occurrences of SSIs include superficial incisional, deep incisional, or organ/space infections related to the surgical incision. Diagnosis will be determined through inpatient clinical monitoring, review of electronic health records for any related outpatient or emergency department visits, and follow-up telephone assessment conducted 30 days after cesarean delivery. SSIs will be summarized by study arm using descriptive statistics.
Secondary Outcomes
- Unscheduled Postoperative Healthcare Visits Related to Wound Concerns(Within 30 days of cesarean delivery/wound dressing application)
- Readmission due to Wound Complications(Within 30 days of cesarean delivery/wound dressing application)
- Reoperation due to Wound Complications(Within 30 days of cesarean delivery/wound dressing application)
- Patient Satisfaction With Postoperative Dressing(At time of dressing removal, up to 7 days after cesarean delivery)
- Occurrence of Wound Seroma Formation(Within 30 days of cesarean delivery/wound dressing application)
- Occurrence of Wound Hematoma Formation(Within 30 days of cesarean delivery/wound dressing application)
- Readmission due to Wound Complications(Within 30 days of cesarean delivery/wound dressing application)
- Occurrence of Wound Dehiscence(Within 30 days of cesarean delivery/wound dressing application)
- Unscheduled Postoperative Healthcare Visits Related to Wound Concerns(Within 30 days of cesarean delivery/wound dressing application)
- Reoperation due to Wound Complications(Within 30 days of cesarean delivery/wound dressing application)
- Patient Satisfaction With Postoperative Dressing(At time of dressing removal, up to 7 days after cesarean delivery)