Trial · NCT07914569
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Number of Participants with Premature Removal of Mepilex Border Post-Op Ag | Up to 7 days after cesarean delivery | 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. |
| Secondary | Number of Participants with Dressing-related Adverse Events | Through study completion, up to 40 days after cesarean delivery | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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