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NCT02838017 · ClinicalTrials.gov registry record · NA
Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
A NA study, sponsored by Endeavor Health.
- Terminated
- Registry status
- NA
- Development phase
- 504
- Enrollment target
NCT02838017 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 504 participants.
The verdict
NCT02838017, a NA study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 504 participants
- Enrollment target
Study Summary
The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.
Interventions
- DEVICE Tissue Adhesive
- DEVICE Sterile strips
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02838017
The ClinicalTrials.gov registry entry for NCT02838017 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 504 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tissue Adhesive is the first listed.
NCT02838017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02838017 about?
NCT02838017 is a clinical study titled "Tissue Adhesive vs. Sterile Strips After Cesarean Delivery". The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\\adhesive. ...
What is the current status of trial NCT02838017?
This trial is currently terminated. It is a NA study. The enrollment target is 504 participants. The study started on 2016-11. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02838017?
The interventions under investigation include: Tissue Adhesive (DEVICE), Sterile strips (DEVICE).
Who is sponsoring clinical trial NCT02838017?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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