The Mepilex Cesarean Delivery Trial

NCT07066254 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-16900
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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. 1.Does Mepilex Ag reduce the rate of surgical site infections after cesarean delivery?
2. 2.Is Mepilex Ag more effective than standard wound dressings in preventing infection?
3. 3.Undergo a routine cesarean delivery as per usual obstetric indication
4. 4.Be randomly assigned to receive either a silver-containing foam dressing or a standard dressing after surgery
5. 5.Be monitored for wound complications and signs of infection during the postpartum period

Conditions

Surgical Site Infection Following Cesarean Delivery

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery

  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.

  Within 30 days of cesarean delivery/wound dressing application

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Standard Surgical Dressing (Telfa non-adhesive pad, gauze, Primapore adhesive bandage)

ACTIVE COMPARATOR

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.

Device: Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)

Mepilex Ag Dressing

EXPERIMENTAL

Participants in this arm will receive a silver-impregnated antimicrobial foam dressing (Mepilex Ag) applied to the surgical incision following cesarean delivery.

Device: Mepilex Ag Dressing

Interventions

Mepilex Ag Dressing DEVICE

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.

Also known as: Mepilex, Mepilex Ag, silver-impregnated antimicrobial foam

Mepilex Ag Dressing

Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage) DEVICE

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.

Also known as: Telfa, Primapore, adhesive bandage, standard dressing, unmedicated dressing

Standard Surgical Dressing (Telfa non-adhesive pad, gauze, Primapore adhesive bandage)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Jack D. Weiler Hospital (Einstein Campus)

The Bronx, New York, 10461, United States

Location

Related Publications (6)

• Talbot GT, Maxwell RA, Griffiths KM, Polenakovik HM, Galloway ML, Yaklic JL. A Risk-Stratified Peri-Operative Protocol for Reducing Surgical Site Infection after Cesarean Delivery. Surg Infect (Larchmt). 2021 May;22(4):409-414. doi: 10.1089/sur.2019.354. Epub 2020 Aug 12.

  PMID: 32783694 BACKGROUND

• Davies P, McCarty S, Hamberg K. Silver-containing foam dressings with Safetac: a review of the scientific and clinical data. J Wound Care. 2017 Jun 1;26(Sup6a):S1-S32. doi: 10.12968/jowc.2017.26.Sup6a.S1.

  PMID: 28594320 BACKGROUND

• Saijo Y, Cho H, Mitsuwa H, Ogawa R. Multilayered Silver-containing Polyurethane-foam (Mepilex Ag) for Tie-over Bolster Fixation of a Skin Graft. Plast Reconstr Surg Glob Open. 2024 Aug 1;12(8):e6018. doi: 10.1097/GOX.0000000000006018. eCollection 2024 Aug.

  PMID: 39534070 BACKGROUND

• Kuo CY, Wootten CT, Tylor DA, Werkhaven JA, Huffman KF, Goudy SL. Prevention of pressure ulcers after pediatric tracheotomy using a Mepilex Ag dressing. Laryngoscope. 2013 Dec;123(12):3201-5. doi: 10.1002/lary.24094. Epub 2013 Jul 29.

  PMID: 23897691 BACKGROUND

• Ball TC, Toy KA, Seoighe DS. The Mepilex Ag glove: A novel burn dressing for hands. Burns. 2025 Mar;51(2):107354. doi: 10.1016/j.burns.2024.107354. Epub 2024 Dec 13. No abstract available.

  PMID: 39721240 BACKGROUND

• Lisiecki JL, Buta MR, Taylor S, Tait M, Farina N, Levin J, Schulz J, Sangji N, Friedstat J, Hemmila MR, Wang S, Levi B, Goverman J. Efficacy of Mepliex(R) Ag Versus Xeroform(R) As A Split-Thickness Skin Graft Donor Site Dressing: Bad Habits Die Hard. Ann Burns Fire Disasters. 2023 Sep 30;36(3):243-250. eCollection 2023 Sep.

  PMID: 38680433 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications; Patient Satisfaction

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Georgios Doulaveris

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Weinstein

CONTACT

3475433542; anweinstei@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized in a 1:1 ratio to receive either Mepilex Ag or the standard surgical dressing post-cesarean delivery.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: 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.

Locations

US (1)