Surgical Site Infection Following Cesarean Delivery
Conditions
Keywords
Surgical site infection, Surgical Wound Infection, Postoperative Complications, Cesarean Section, Obstetric Surgical Procedures, Pregnant Women, Wound Dressing, Randomized Controlled Trial, Patient satisfaction, Anti-Infective Agents, Local, Infection Control, silver antimicrobial foam, mepilex
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: 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
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.
Interventions
DEVICEMepilex Ag Dressing
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.
DEVICEStandard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Eligible participants will be randomized in a 1:1 ratio to receive either Mepilex Ag or the standard surgical dressing post-cesarean delivery.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Postoperative Dressing | At time of dressing removal, up to 7 days after cesarean delivery | Patient satisfaction will be assessed using the Adapted Wound Dressing Satisfaction Questionnaire (WDSQ), a 9-item instrument that evaluates comfort, ease of movement, perceived wound protection, dressing appearance, and skin irritation. Responses to the first 8 questions are rated on a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The final item is rated on an 11-point Likert scale, ranging from 0 (Not at all satisfied) to 10 (Extremely satisfied), for an overall possible scoring range of 8-50, wherein higher scores are associated with increased global satisfaction with the assigned dressing. |
| Occurrence of Wound Seroma Formation | Within 30 days of cesarean delivery/wound dressing application | Presence of a wound seroma at the surgical site, identified through documentation in the medical record within the 30 day postoperative period, will be summarized by study arm using basic descriptive statistics. |
| Occurrence of Wound Hematoma Formation | Within 30 days of cesarean delivery/wound dressing application | Presence of a wound hematoma at the surgical site, identified through documentation in the medical record within the 30-day postoperative period, will be summarized by study arm using basic descriptive statistics. |
| Occurrence of Wound Dehiscence | Within 30 days of cesarean delivery/wound dressing application | Presence of partial or complete wound dehiscence at the surgical site, identified through documentation in the medical record within the 30-day postoperative period, will be summarized by study arm using basic descriptive statistics. |
| Unscheduled Postoperative Healthcare Visits Related to Wound Concerns | Within 30 days of cesarean delivery/wound dressing application | The number of unscheduled patient visits (either emergency department or outpatient clinic) related to wound complications, including concerns about drainage, infection, dehiscence, or dressing problems will be summarized by study arm using basic descriptive statistics. |
| Readmission due to Wound Complications | Within 30 days of cesarean delivery/wound dressing application | Hospital readmission events occurring within 30 days postoperatively that are attributable to wound-related issues, including surgical site infection or wound breakdown will be summarized by study arm using basic descriptive statistics. |
| Reoperation due to Wound Complications | Within 30 days of cesarean delivery/wound dressing application | The occurrence of a return to the operating room for a wound-related complication (e.g., infection, dehiscence, hematoma evacuation) within the 30-day postoperative period, as documented in the medical record, will be summarized by study arm using basic descriptive statistics. |
Contacts
PRINCIPAL_INVESTIGATORGeorgios Doulaveris
Montefiore Medical Center
Outcome results
None listed