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Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Sponsor: Major Extremity Trauma Research Consortium
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.
Official title: Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2025-01-01
Completion Date
2028-12-31
Last Updated
2025-05-02
Healthy Volunteers
No
Interventions
Incisional Negative Pressure Wound Therapy (NPWT)
Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and \>3cm in length.
Locations (2)
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States