What this study is
Simplified from ClinicalTrials.govTesting a silver-containing foam dressing (Mepilex Border Post-Op Ag) to see whether it works as well as the standard dressing at preventing infection of the cut (surgical site infection) in women aged 18 and older who are having a cesarean delivery.
Read the original summary from ClinicalTrials.gov
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:
1. Have their cesarean delivery as planned by their care team 2. Be randomly assigned to one of the two dressings, which is placed over the incision at the end of surgery 3. Complete a short questionnaire about their dressing 4. Receive a follow-up phone call about 30 to 40 days after delivery (POD 30-40) to check on their wound
What's being tested
- Mepilex Border Post-Op Ag
Intervention · DEVICE
An FDA-cleared (510(k) K100029), self-adherent, silver-containing soft silicone foam dressing (Mölnlycke Health Care) indicated for postoperative wounds. Applied according to manufacturer labeling.
- Standard Postoperative Dressing
Intervention · DEVICE
A sterile Telfa non-adherent pad (Cardinal Health) covered with sterile gauze and secured with a Primapore adhesive dressing (Smith \& Nephew). This is the institution's routine postoperative cesarean dressing.
Study details
- Official title
- A Randomized Controlled Non-Inferiority Trial of Mepilex Border Post-Op Ag Versus Standard Postoperative Dressing Following Cesarean Delivery
- Sponsor
- Montefiore Medical Center
- Conditions
- Surgical Site Infection
- Enrolling
- 240 people
- Starts
- 2026-11
- Est. completion
- 2027-11
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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?
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMontefiore-Einstein Jack D. Weiler Hospital
The Bronx, New York, United States
- Anna Weinstein, DO · Contact347-543-3542anweinstei@montefiore.org
- Lilly Liu, MD, MPH · Contact
- Lilly Liu, MD, MPH · Principal investigator
Study team
Sponsor
Montefiore Medical Center
Study ID 2026-544
Principal investigator
Lilly Liu, MD, MPH
Montefiore Medical Center
CONTACT
Lilly Liu
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.