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NCT02578745 · ClinicalTrials.gov registry record · NA
Prophylactic Incisional Care in Obese Women at Cesarean
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT02578745 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 120 participants.
The verdict
NCT02578745, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Although effectiveness of prophylactic NPWT is biologically plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is lacking. The objective of this pilot randomized controlled trial of 120 patients to test the hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after cesarean in obese women. The investigators will randomly assign obese women undergoing cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for Disease Control and Prevention (CDC) criteria and other wound complications (separation, hematoma, seroma) after cesarean. Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of wound complications; patient pain and satisfaction scores; physician office visit or emergency department (ED) visits for SSIs; and hospital readmission for wound complications.
Interventions
- OTHER Standard Dressing
- DEVICE Prophylactic NPWT (PICO system)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02578745
The ClinicalTrials.gov registry entry for NCT02578745 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Dressing is the first listed.
NCT02578745 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02578745 about?
NCT02578745 is a clinical study titled "Prophylactic Incisional Care in Obese Women at Cesarean". Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing ...
What is the current status of trial NCT02578745?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2015-10. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02578745?
The interventions under investigation include: Standard Dressing (OTHER), Prophylactic NPWT (PICO system) (DEVICE).
Who is sponsoring clinical trial NCT02578745?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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