AzTrials
AzTrials

Surgical Site InfectionMEPIDELNCT07914569

The Mepilex Cesarean Delivery Trial / MEPIDEL

A study testing Mepilex Border Post-Op Ag and Standard Postoperative Dressing in people with Surgical Site Infection, run by Montefiore Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Surgical Site Infection
What is being tested?
Mepilex Border Post-Op Ag and Standard Postoperative Dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Nov 2026to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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?

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Weinstein, DO contact

347-543-3542

anweinstei@montefiore.org

Lilly Liu contact

United States1 site

  • Montefiore-Einstein Jack D. Weiler Hospital

    The Bronx, New York, 10461

    Anna Weinstein, DO, 347-543-3542, anweinstei@montefiore.org

    Lilly Liu, MD, MPH

Other trials in United States

About this study

Official title: A Randomized Controlled Non-Inferiority Trial of Mepilex Border Post-Op Ag Versus Standard Postoperative Dressing Following Cesarean Delivery

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?

Read more

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
Read the detailed description

Surgical site infection (SSI) is one of the most common complications of cesarean delivery and can lead to added treatment, longer hospital stays, readmission, and additional procedures. Risk is higher in patients with obesity, diabetes, prolonged rupture of membranes, intraamniotic infection, or a prior cesarean delivery. Many of these risk factors are common in the patient population served by the study site, where SSI rates approaching 10% after cesarean delivery have been observed.

The postoperative dressing is a potentially modifiable part of surgical care. Standard cesarean dressings provide a physical barrier over the incision but have no antimicrobial properties and offer limited moisture or drainage control. Silver-containing dressings have been studied in several surgical fields because of the antimicrobial properties of ionic silver. However, silver dressings vary widely in design. A prior randomized trial of a silver nylon mesh dressing after cesarean delivery found no reduction in SSI compared with standard care. That dressing differs substantially from multilayer silver foam dressings with silicone adhesive, such as Mepilex Border Post-Op Ag, so its findings may not apply to foam-based products.

Mepilex Border Post-Op Ag is FDA-cleared and already used in routine clinical practice at the study institution, but prospective data on its performance after cesarean delivery are limited, particularly in higher-risk obstetric populations. Before broader use can be supported, it is important to confirm that wound outcomes are not worse than with the standard dressing. This study therefore uses a non-inferiority design. An increase in SSI of more than 5 percentage points was judged clinically unacceptable, based on clinical judgment, published cesarean SSI data, and expected baseline infection rates at the study site. If non-inferiority is shown, secondary analyses will examine whether the foam dressing offers additional benefit.

Patient experience is also an important part of postoperative recovery. Comfort, mobility, confidence in wound protection, and ease of dressing care may differ between dressings, so participant-reported satisfaction is collected alongside clinical wound outcomes.

Being tested
Mepilex Border Post-Op Ag, Standard Postoperative Dressing
Keywords
Cesarean Delivery, Surgical Site Infection, Postoperative Complications, Cesarean Section, Pregnant Women, Wound Dressing, Patient satisfaction, Occlusive Dressings, Infection Control, Silver antimicrobial foam, Mepilex Border Post-Op Ag
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 Border Post-Op AgDevice

    Also called Silver-impregnated antimicrobial foam dressing

    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 DressingDevice

    Also called Telfa, Primapore

    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 groups in NCT07914569
Study groupRoleWhat they receive
Mepilex Border Post-Op AgExperimentalParticipants will receive a single Mepilex Border Post-Op Ag dressing applied over the cesarean incision immediately after skin closure in the operating room. The dressing is intended to remain in place until approximately postoperative day 7 (POD 7) unless earlier removal is clinically indicated or requested by the participant. If the dressing is removed early, it may be replaced at the treating physician's discretion.
Receives: Device: Mepilex Border Post-Op Ag
Standard Postoperative DressingActive comparatorParticipants will receive the institution's standard postoperative cesarean dressing, applied over the incision immediately after skin closure in the operating room. The dressing is typically removed on POD 1 or POD 2 according to routine institutional practice.
Receives: Device: Standard Postoperative Dressing

What is being measured

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

  1. Number of participants with surgical site infection (SSI) within 30 days of cesarean delivery

    SSI will be defined by Centers for Disease Control and Prevention (CDC) criteria, including superficial incisional, deep incisional, and organ-space infections. SSI will be identified through provider documentation in the electronic medical record, outpatient wound evaluations, emergency department encounters, readmissions, antibiotic treatment for wound infection, wound drainage or debridement, reoperation, or participant report confirmed by clinical documentation. Data will be collected during hospitalization (POD 1-2), at the routine postoperative wound evaluation (POD 7-14, Mepilex Border Post-Op Ag arm only), and by medical record review and telephone follow-up (POD 30-40). All potential SSIs will be adjudicated by the PI or designee according to CDC criteria prior to final outcome classification. Participants with SSI occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of episodes.

    Measured: Up to 30 days after cesarean delivery

Secondary outcomes (11)

  1. Number of Participants with Wound Dehiscence

    Wound dehiscence will be defined as partial or complete separation of the cesarean incision documented by a clinical provider. Wound dehiscence data will be collected during hospitalization (POD 1-2), at the routine postoperative wound evaluation (POD 7-14, Mepilex Border Post-Op Ag arm only), and by medical record review and telephone follow-up (POD 30-40). Participants with wound dehiscence occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of episodes.

    Measured: Up to 30 days after cesarean delivery

  2. Number of Participants with Wound Seroma

    Wound seroma will be defined as a clinically documented localized collection of serous fluid at or beneath the incision. Wound seroma data will be collected during hospitalization (POD 1-2), at the routine postoperative wound evaluation (POD 7-14, Mepilex Border Post-Op Ag arm only), and by medical record review and telephone follow-up (POD 30-40). Participants with wound seroma occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of episodes.

    Measured: Up to 30 days after cesarean delivery

  3. Number of Participants with Wound Hematoma

    Wound hematoma will be defined as a clinically documented collection of blood at or beneath the incision. Wound hematoma data will be collected during hospitalization (POD 1-2), at the routine postoperative wound evaluation (POD 7-14, Mepilex Border Post-Op Ag arm only), and by medical record review and telephone follow-up (POD 30-40). Participants with wound hematoma occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of episodes.

    Measured: Up to 30 days after cesarean delivery

  4. Number of Participants with a Wound-related Emergency Department or Triage Visit

    The number of participants with at least one emergency department (ED) or triage visit for a wound-related concern will be assessed. Data will be collected by medical record review and telephone follow-up (POD 30-40). Participants with at least one wound-related ED or triage visit occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of visits.

    Measured: Up to 30 days after cesarean delivery

  5. Number of Participants with a Wound-related Outpatient Evaluation

    The number of participants with at least one unscheduled outpatient evaluation for a wound-related concern will be assessed. Data will be collected by medical record review and telephone follow-up (POD 30-40). Participants with at least one wound-related outpatient evaluation occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of evaluations.

    Measured: Up to 30 days after cesarean delivery

  6. Number of Participants with Hospital Readmission for Wound-related Concern or Postoperative Infection

    The number of participants who were readmitted to the hospital for a wound-related concern or postoperative infection will be assessed. Data will be collected by medical record review and telephone follow-up (POD 30-40). Participants with at least one readmission occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of readmissions.

    Measured: Up to 30 days after cesarean delivery

  7. Number of Participants with Reoperation for a Wound-related Complication

    The number of participants who returned to the operating room for a wound-related complication will be assessed. Data will be collected by medical record review and telephone follow-up (POD 30-40). Participants with at least one reoperation occurring from cesarean delivery through POD 30 will be counted once, regardless of the number of reoperations.

    Measured: Up to 30 days after cesarean delivery

  8. Patient-reported Dressing Satisfaction

    Patient-reported dressing satisfaction will be assessed using the study-specific Dressing Satisfaction Questionnaire (DSQ). Items 1-8 of the DSQ are individually rated using a 5-point Likert scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Item 7 (itching or discomfort) is reverse scored. A summary score will be calculated by summing Items 1-8, after reverse-scoring Item 7, yielding an overall possible score ranging from 8-40, with higher scores indicating greater overall dressing satisfaction. Participants whose dressing was removed early will answer based on the time it was in place. DSQ will be administered on postoperative day 1-2 (target day 2) for the standard dressing arm and on postoperative days 7-14 for the Mepilex Border Post-Op Ag arm.

    Measured: Up to 14 days after cesarean delivery; Postoperative day 1-2 (target Postoperative day 2) for the standard postoperative dressing arm; Postoperative day 7-14 (POD 7-14) for the Mepilex Border Post-Op Ag arm

  9. DSQ Overall Satisfaction Rating (Item 9)

    Patient-reported overall dressing satisfaction will be assessed using Item 9 of the DSQ. Item 9 assesses overall dressing satisfaction on a 0-10 scale rated from 0 ("Not at all satisfied") to 10 ("Extremely satisfied"), such that higher scores are indicative of greater overall satisfaction. Participants whose dressing was removed early will answer based on the time it was in place.

    Measured: Up to 14 days after cesarean delivery; Postoperative Day 1-2 (target Postoperative day 2) for the standard postoperative dressing arm; Postoperative day 7-14 (POD 7-14) for the Mepilex Border Post-Op Ag arm

  10. Number of Participants with Premature Removal of Mepilex Border Post-Op Ag

    The number of participants in the Mepilex Border Post-Op Ag arm with removal of the study dressing before the end of the intended wear period (POD 7) for any reason (e.g., participant request, discomfort, displacement, saturation, concern for infection, skin reaction, provider preference, or other clinical indication) will be assessed. Data will be collected by medical record review during hospitalization (POD 1-2) and at the routine postoperative wound evaluation (POD 7-14). Participants with premature removal occurring from cesarean delivery through POD 7 will be counted once, regardless of the number of removals or dressing replacements. This outcome will be reported for the Mepilex Border Post-Op Ag arm only, because the standard dressing is routinely removed on POD 1-2.

    Measured: Up to 7 days after cesarean delivery

  11. Number of Participants with Dressing-related Adverse Events

    The number of participants with at least one adverse event attributed to the postoperative dressing (e.g., skin irritation, rash, blistering, contact dermatitis, allergic reaction, discomfort, wound maceration, or other provider-documented dressing-related concern) will be assessed. Dressing displacement and premature removal are dressing-performance outcomes and are not adverse events in isolation; an associated clinically significant event (e.g., skin injury, allergic reaction, or wound complication) will be evaluated as an adverse event. Data will be collected through inpatient documentation, the routine postoperative wound evaluation, participant report, telephone follow-up, and medical record review. Attribution to the dressing will be determined by the PI or designee. Participants with at least one dressing-related adverse event occurring from randomization through completion of follow-up will be counted once, regardless of the number of events.

    Measured: Through study completion, up to 40 days after cesarean delivery

Timeline

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

  1. First posted3 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

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
Participants will be randomized in a 1:1 allocation ratio to receive either Mepilex Border Post-Op Ag or the standard postoperative dressing, applied after cesarean skin closure, to assess non-inferiority with respect to surgical site infection within 30 days.
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07914569
Sponsor's protocol ID
2026-544
Other IDs
2026-544
Acronym
MEPIDEL
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Temming LA, Raghuraman N, Carter EB, Stout MJ, Rampersad RM, Macones GA, Cahill AG, Tuuli MG. Impact of evidence-based interventions on wound complications after cesarean delivery. Am J Obstet Gynecol. 2017 Oct;217(4):449.e1-449.e9. doi: 10.1016/j.ajog.2017.05.070. Epub 2017 Jun 8.

    PubMed 28601567

  • Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

    PubMed 28796687

  • 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

  • Goodman JR, Durazo-Arvizu R, Nashif S, McAlarnen LA, Wagner SA, Lal AK. Preventing caesarean section wound complications: use of a silver-impregnated antimicrobial occlusive dressing. J Wound Care. 2022 Jul 1;31(Sup7):S5-S14. doi: 10.12968/jowc.2022.31.Sup7.S5.

    PubMed 35797250

  • Wijetunge S, Hill R, Katie Morris R, Hodgetts Morton V. Advanced dressings for the prevention of surgical site infection in women post-caesarean section: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:226-233. doi: 10.1016/j.ejogrb.2021.11.014. Epub 2021 Nov 11.

    PubMed 34826671

  • Connery SA, Yankowitz J, Odibo L, Raitano O, Nikolic-Dorschel D, Louis JM. Effect of using silver nylon dressings to prevent superficial surgical site infection after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol. 2019 Jul;221(1):57.e1-57.e7. doi: 10.1016/j.ajog.2019.02.053. Epub 2019 Mar 5.

    PubMed 30849351

  • Connery S, Tanner JP, Odibo L, Raitano O, Nikolic-Dorschel D, Louis JM. Effect of Using Silver Nylon Dressings on Postoperative Pain after Cesarean Delivery. Am J Perinatol. 2023 Dec;40(16):1811-1819. doi: 10.1055/s-0041-1739521. Epub 2021 Nov 28.

    PubMed 34839470

  • Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.

    PubMed 26551196

  • Kostenko V, Lyczak J, Turner K, Martinuzzi RJ. Impact of silver-containing wound dressings on bacterial biofilm viability and susceptibility to antibiotics during prolonged treatment. Antimicrob Agents Chemother. 2010 Dec;54(12):5120-31. doi: 10.1128/AAC.00825-10. Epub 2010 Sep 20.

    PubMed 20855737

  • Percival SL, McCarty SM. Silver and Alginates: Role in Wound Healing and Biofilm Control. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):407-414. doi: 10.1089/wound.2014.0541.

    PubMed 26155383

  • Yousefian F, Hesari R, Jensen T, Obagi S, Rgeai A, Damiani G, Bunick CG, Grada A. Antimicrobial Wound Dressings: A Concise Review for Clinicians. Antibiotics (Basel). 2023 Sep 11;12(9):1434. doi: 10.3390/antibiotics12091434.

    PubMed 37760730

  • Doherty C, Byrne CV, Baqader S, El-Chami C, McBain AJ, Thomason HA. Anti-biofilm effects and healing promotion by silver oxynitrate-based dressings. Sci Rep. 2023 Feb 3;13(1):2014. doi: 10.1038/s41598-022-26856-x.

    PubMed 36737464

  • Du Y, Lu J, Guo X, Xia Z, Ji S. The Role of Silver and Silver-Based Products in Wound Management: A Review of Advances and Current Landscape. J Funct Biomater. 2026 Jan 1;17(1):27. doi: 10.3390/jfb17010027.

    PubMed 41590795

Questions about this trial

What is this clinical trial studying?

A study testing Mepilex Border Post-Op Ag and Standard Postoperative Dressing in people with Surgical Site Infection, run by Montefiore Medical Center at 1 site in United States.

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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Anna Weinstein, DO (347-543-3542, anweinstei@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with surgical site infection (SSI) within 30 days of cesarean delivery (time frame: Up to 30 days after cesarean delivery). 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 NCT07914569, which also lists 13 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 3 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in