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NCT03061903 · ClinicalTrials.gov registry record · NA
Closed Incision Negative Pressure Therapy vs Standard of Care
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
NCT03061903 is a NA study that has completed, run by Columbia University. The registered enrollment target is 122 participants.
The verdict
NCT03061903, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
Study Summary
High risk patients who receive direct anterior approach total hip arthroplasty are more likely to experience wound complications. The purpose of this study is to determine whether the usage of closed incision negative pressure dressings decreases the risk of wound complication compared to standard dressings. Patients who decide to participate in the study will be randomized to one of the two dressing prior to surgery and will leave the operating room with one of the treating dressings. Patient will be monitored 90 days after surgery for wound complications and pictures of the wounds will be taken. The patients course of treatment besides being randomized to one of the two dressings will be identical to any other patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA). The primary outcome measure will be uneventful wound healing (requiring no intervention) versus the occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound). Secondary outcome measures will include duration of wound healing delay, length of hospital stay, number of days of antibiotic therapy, and direct and estimated indirect costs.
Interventions
- DEVICE Prevena
- DEVICE Aquacel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2022-03-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03061903
The ClinicalTrials.gov registry entry for NCT03061903 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prevena is the first listed.
NCT03061903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03061903 about?
NCT03061903 is a clinical study titled "Closed Incision Negative Pressure Therapy vs Standard of Care". High risk patients who receive direct anterior approach total hip arthroplasty are more likely to experience wound complications. The purpose of this study is to determine whether the usage of closed incision negative pressure dressings decreases the risk of wound complication compared to standard d...
What is the current status of trial NCT03061903?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2018-05-14. Estimated completion is 2022-03-07.
What interventions are being tested in trial NCT03061903?
The interventions under investigation include: Prevena (DEVICE), Aquacel (DEVICE).
Who is sponsoring clinical trial NCT03061903?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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