Trial · NCT07914569
The Mepilex Cesarean Delivery Trial / MEPIDEL
NCT07914569, Not applicable, Recruiting, Montefiore Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Mepilex Cesarean Delivery Trial / MEPIDEL. Trials, record NCT07914569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Mepilex Cesarean Delivery Trial / MEPIDEL
- NCT number
- NCT07914569
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Surgical Site Infection
- Interventions
- Mepilex Border Post-Op Ag, Standard Postoperative Dressing
- First posted
- 2026-11-03
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with surgical site infection (SSI) within 30 days of cesarean delivery | Up to 30 days after 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. |
| Secondary | Number of Participants with Wound Dehiscence | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with Wound Seroma | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with Wound Hematoma | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with a Wound-related Emergency Department or Triage Visit | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with a Wound-related Outpatient Evaluation | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with Hospital Readmission for Wound-related Concern or Postoperative Infection | Up to 30 days after cesarean delivery | 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. |
| Secondary | Number of Participants with Reoperation for a Wound-related Complication | Up to 30 days after cesarean delivery | 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. |
| Secondary | Patient-reported Dressing Satisfaction | 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 | 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. |
| Secondary | DSQ Overall Satisfaction Rating (Item 9) | 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 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07914569
GET https://conductscience.org/api/trials/v1/NCT07914569/registered