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NCT03321799 · ClinicalTrials.gov registry record · Phase 1
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
A Phase 1 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 201
- Enrollment target
NCT03321799: Completed Phase 1 study, sponsored by Rush University Medical Center.
NCT03321799 is a Phase 1 study that has completed, run by Rush University Medical Center. The registered enrollment target is 201 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03321799, a Phase 1 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 201 participants
- Enrollment target
Study Summary
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.
Primary Outcome
Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for \>7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation.
Interventions
- DEVICE Negative Pressure Wound Therapy (NPWT)
- DEVICE Sterile Antimicrobial Dressings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2017-04-28 |
| Est. Completion | 2025-07-11 |
| Phase | Phase 1 |
What the finished NCT03321799 record still lists
NCT03321799 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (235% higher).
The record links to 0 conditions, and to 2 interventions - of which Negative Pressure Wound Therapy (NPWT) is the first listed.
NCT03321799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03321799 about?
NCT03321799 is a clinical study titled "Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA". Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revi...
What is the current status of trial NCT03321799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 201 participants. The study started on 2017-04-28. Estimated completion is 2025-07-11.
What interventions are being tested in trial NCT03321799?
The interventions under investigation include: Negative Pressure Wound Therapy (NPWT) (DEVICE), Sterile Antimicrobial Dressings (DEVICE).
Who is sponsoring clinical trial NCT03321799?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03321799's enrollment target sits among peer trials
201 258th of 2000 higher than 1,742 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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