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.
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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…
Contacts

Leah Gitajn, MD

603-650-5133

ida.leah.gitajn@hitchcock.org

CONTACT