Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Start Date
1/1/2025
Completion Date
12/31/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Incisional Negative Pressure Wound Therapy (NPWT)
Conditions
Locations
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland 21201
United States
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland 21201
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Vanderbilt University
Nashville, Tennessee 37232
United States
UTHealth/McGovern Medical School
Houston, Texas 77030
United States
Inova Fairfax MEdical Campus
Falls Church, Virginia 22042
United States