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Surgical Site Infection Following Cesarean DeliveryMEPIDELNCT07066254

The Mepilex Cesarean Delivery Trial

A study testing Mepilex Ag Dressing and Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage) in people with Surgical Site Infection Following Cesarean Delivery, run by Montefiore Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Mepilex Ag Dressing and Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2026to Feb 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: A Randomized Controlled Trial on the Effect of a Silver-impregnated Antimicrobial Foam Dressing on Surgical Site Infections After Cesarean Delivery

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?
Read more

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
Read the 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.

Being tested
Mepilex Ag Dressing, Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
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
Medical subject headings
Surgical Wound Infection, Postoperative Complications, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mepilex Ag DressingDevice

    Also called Mepilex, Mepilex Ag, silver-impregnated antimicrobial foam

    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.

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

    Also called Telfa, Primapore, adhesive bandage, standard dressing

    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.

Study groups in NCT07066254
Study groupRoleWhat they receive
Standard Surgical Dressing (Telfa non-adhesive pad, gauze, Primapore adhesive bandage)Active comparatorParticipants 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.
Receives: Device: Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
Mepilex Ag DressingExperimentalParticipants in this arm will receive a silver-impregnated antimicrobial foam dressing (Mepilex Ag) applied to the surgical incision following cesarean delivery.
Receives: Device: Mepilex Ag Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

Secondary outcomes (7)

  1. Patient Satisfaction With Postoperative Dressing

    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.

    Measured: At time of dressing removal, up to 7 days after cesarean delivery

  2. Occurrence of Wound Seroma Formation

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

  3. Occurrence of Wound Hematoma Formation

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

  4. Occurrence of Wound Dehiscence

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

  5. Unscheduled Postoperative Healthcare Visits Related to Wound Concerns

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

  6. Readmission due to Wound Complications

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

  7. Reoperation due to Wound Complications

    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.

    Measured: Within 30 days of cesarean delivery/wound dressing application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study startApr 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Why it stopped: Proposed superiority study framework was not approved by the IRB. Study will be redeveloped as a non-inferiority study and resubmitted to the IRB.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07066254
Sponsor's protocol ID
2025-16900
Other IDs
2025
Acronym
MEPIDEL
Status last verified
Jun 2026
First submitted
4 Jul 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) to be shared will include all data that underlie the results reported in any publication arising from the trial. This includes demographic and clinical characteristics, intraoperative details, incidence of surgical site infections and other wound complications, and patient-reported outcomes from the wound dressing satisfaction questionnaire. No personal identifiers will be shared.

Publications

  • 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.

    PubMed 32783694

  • 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.

    PubMed 28594320

  • 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.

    PubMed 39534070

  • 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.

    PubMed 23897691

  • 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.

    PubMed 39721240

  • 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.

    PubMed 38680433

Questions about this trial

What is this clinical trial studying?

A study testing Mepilex Ag Dressing and Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage) in people with Surgical Site Infection Following Cesarean Delivery, run by Montefiore Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Surgical Site Infection (SSI) Within 30 Days Post-Cesarean Delivery (time frame: Within 30 days of cesarean delivery/wound dressing application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07066254, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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