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
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
Brief Title
The Mepilex Cesarean Delivery Trial
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
SURGICAL SITE INFECTION FOLLOWING CESAREAN DELIVERY
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07066254
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-16900
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Controlled Trial on the Effect of a Silver-impregnated Antimicrobial Foam Dressing on Surgical Site Infections After Cesarean Delivery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Secondary Ids
Secondary Id
2025
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
At time of dressing removal, up to 7 days after cesarean delivery
Outcome Measure
Patient Satisfaction With Postoperative Dressing
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Occurrence of Wound Seroma Formation
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Occurrence of Wound Hematoma Formation
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Occurrence of Wound Dehiscence
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Unscheduled Postoperative Healthcare Visits Related to Wound Concerns
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Readmission due to Wound Complications
Outcome Description
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.
Outcome Time Frame
Within 30 days of cesarean delivery/wound dressing application
Outcome Measure
Reoperation due to Wound Complications
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lilly Liu
Investigator Email
lilliu@montefiore.org
Investigator Sponsor Organization
Montefiore
Study Department
Obstetrics & Gynecology and Women`s Health
Study Division
Maternal Fetal Medicine
Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
SURGICAL WOUND INFECTION
POSTOPERATIVE COMPLICATIONS
PATIENT SATISFACTION
WOUND INFECTION
INFECTIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
TREATMENT ADHERENCE AND COMPLIANCE
HEALTH BEHAVIOR
BEHAVIOR