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Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
Led by Major Extremity Trauma Research Consortium · Updated on 2026-05-12
352
Participants Needed
6
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of incisional negative pressure wound therapy (NPWT) compared to standard wound care in patients with high-risk fractures of the tibia. This study involves adults who have open or closed tibial plateau fractures, tibial pilon fractures, or open tibial shaft fractures with surgical incisions larger than 3 cm. The goal is to assess whether NPWT can reduce infection and wound complications three months after treatment. Participants will be randomly assigned to one of two groups: one receiving standard wound dressing care and the other receiving NPWT using a device that applies continuous suction to the surgical incision. The NPWT device uses a vacuum-assisted closure (VAC) sponge placed over the wound, delivering suction at 75-125 mmHg. This treatment begins after operative fixation or debridement and continues as part of the definitive wound management. During the study, participants will be followed for at least three months to monitor wound healing and complications. Researchers will collect data on infection rates, wound dehiscence, and other wound-related issues. The primary outcome is a combined measure of complications assessed three months after randomization. Participants' progress will be tracked without masking, and the study aims to provide clear evidence about the benefits and risks of NPWT in managing high-risk tibial fractures.
CONDITIONS
Brief 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...
- Adults 18 years or older
- Open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complications
- Open Gustilo Type I, II, or IIIA tibial shaft fractures treated 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 has resolved
- Any open Type I, II, or IIIA fracture regardless of timing of definitive treatment
- Tibial plateau fractures with ipsilateral leg compartment syndrome fasciotomy wounds with at least one wound primarily closed
- Surgical incision of 3 cm or greater required for fixation or debridement
You will not qualify if you...
- Injury is infected at the time of study enrollment
- Unable to receive incisional NPWT for any reason
- Already had definitive fixation prior to enrollment
- Severe difficulties with follow-up, such as homelessness, lack of family support, intellectual challenges, or imprisonment
- Gustilo Type IIIB or IIIC open fractures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo surgery with an incision of 3 cm or greater, followed by the application of either standard wound care or incisional negative pressure wound therapy using a vacuum system.
Approximately 6 post-operative visits
Duration - Up to 3 months after treatment
Participants are monitored for wound complications and infections following treatment.
Regular visits for monitoring during the 3-month period
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
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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