Actively Recruiting
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Led by Major Extremity Trauma Research Consortium · Updated on 2026-05-12
352
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 compartment syndrome if at least one wound is primarily closed
- High-risk fractures defined as closed fractures initially treated with an external fixator and definitive treatment more than 3 days later after swelling resolves
- Any open type I, II or IIIA fracture, regardless of timing of definitive treatment
- Any tibial plateau fracture with ipsilateral leg compartment syndrome fasciotomy wounds with at least one wound primarily closed
- Requiring incision for fixation or debridement of 3 cm or greater
- Patients 18 years of age or older
You will not qualify if you...
- The injury is already infected at time of study enrollment
- Unable to receive incisional negative pressure wound therapy for any reason
- Already had definitive fixation prior to enrollment
- Severe problems maintaining follow-up, such as homelessness, intellectual challenges without support, or prisoner status
- Injury is a Gustilo Type IIIB or IIIC open fracture
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
4
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
UTHealth/McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
6
Inova Fairfax MEdical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
L
Leah Gitajn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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