Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

Recruiting now · Phase 3

Conditions studied: Fracture of Tibia, Wound Heal, Infected Wound, Wound Complication, Wound Dehiscence

In brief

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.

Key facts

Study ID

NCT06337292

Run by

Major Extremity Trauma Research Consortium

People needed

352

Starts

2025-01-01

Expected to finish

2028-12-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• We define high-risk fractures as those that are either:
• Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
• Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
• Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has 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 may not qualify if…

• The study injury is already infected at time of study enrollment.
• Patient is unable to receive incisional NPWT for any reason.
• Patients who have already had definitive fixation prior to enrollment in the study.
• Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
• The study injury is a Gustilo Type IIIB or IIIC open fracture.

Where it is running

• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (enrolling)
• University of Maryland Shock Trauma/Capitol Regions — Baltimore, Maryland, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• UTHealth/McGovern Medical School — Houston, Texas, United States (enrolling)
• Inova Fairfax MEdical Campus — Falls Church, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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