Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Recruiting
Phase 3
Interventional Study
Fracture of Tibia
Wound Heal
Infected Wound
Wound Complication
Wound Dehiscence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 352 (estimated)
- Sponsor
- Major Extremity Trauma Research Consortium · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg com…
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