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NCT06337292 · ClinicalTrials.gov registry record · Phase 3
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
A Phase 3 study of Wound Heal and Fracture of Tibia, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 352
- Enrollment target
- 2
- Study locations
NCT06337292: Recruiting Phase 3 study of Wound Heal and Fracture of Tibia, sponsored by Major Extremity Trauma Research Consortium.
NCT06337292 is a Phase 3 study of Wound Heal and Fracture of Tibia that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 352 participants, above the 104-participant average among 23 other Wound Heal trials with a reported enrollment target (238% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06337292, a Phase 3 study of Wound Heal and Fracture of Tibia, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 352 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome.
Primary Outcome
The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom
Conditions Studied
Interventions
- DEVICE Incisional Negative Pressure Wound Therapy (NPWT)
Study Locations (2)
Maryland
- University of Maryland R Adams Cowley Shock Trauma Center - Baltimore
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT06337292 shows while recruiting
NCT06337292 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 23 other Wound Heal trials with a reported enrollment target (238% higher).
The record links to 5 conditions, with Wound Heal appearing as the primary indexed condition, and to 1 intervention - of which Incisional Negative Pressure Wound Therapy (NPWT) is the first listed.
NCT06337292 reports a single indexed study location in Maryland, New Hampshire.
Frequently Asked Questions
What is clinical trial NCT06337292 about?
NCT06337292 is a clinical study titled "Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures". This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to rece...
What is the current status of trial NCT06337292?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2025-01-01. Estimated completion is 2028-12-31.
What conditions does trial NCT06337292 study?
This clinical trial studies the following conditions: Wound Heal, Fracture of Tibia, Infected Wound, Wound Complication, Wound Dehiscence.
What interventions are being tested in trial NCT06337292?
The interventions under investigation include: Incisional Negative Pressure Wound Therapy (NPWT) (DEVICE).
Who is sponsoring clinical trial NCT06337292?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06337292 being conducted?
This trial has 2 study locations across Maryland, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06337292's enrollment target sits among peer trials
352 1st of 23 higher than 23 of 23 other Wound Heal trials
participants (enrollment target), bucketed by value
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