Using negative pressure therapy to improve healing in high-risk fractures

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

This study is testing if a special type of wound therapy can help people with high-risk tibial fractures heal better and avoid infections compared to regular bandages.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Major Extremity Trauma Research Consortium (Academic / other)
• Locations: 6 sites (Baltimore, Maryland and 5 other locations)
• Trial ID: NCT06337292 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of incisional negative pressure wound therapy (NPWT) compared to standard wound dressing in patients with high-risk tibial fractures. It involves a multi-center, randomized controlled design with 352 participants who will be monitored for clinical outcomes three months post-treatment. The study aims to assess the incidence of infections and complications associated with wound healing in this patient population. The primary outcome is a composite measure of clinical status, while secondary outcomes will evaluate individual components of the primary outcome.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with high-risk open or closed tibial plateau or pilon fractures requiring surgical intervention.

Not a fit: Patients with low-risk fractures or those not requiring surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce infection rates and complications in patients with high-risk fractures.

How similar studies have performed: Previous studies have shown promising results with negative pressure wound therapy in various surgical contexts, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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
3. Requiring incision for fixation or debridement of 3 cm or greater.
4. Patients 18 years of age or older

Exclusion Criteria:

1. The study injury is already infected at time of study enrollment.
2. Patient is unable to receive incisional NPWT for any reason.
3. Patients who have already had definitive fixation prior to enrollment in the study.
4. 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).
5. The study injury is a Gustilo Type IIIB or IIIC open fracture.

Where this trial is running

Baltimore, Maryland and 5 other locations

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

Study contacts

• Principal investigator: I. Leah Gitajn, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Leah Gitajn, MD

Conditions Fracture of Tibia; Wound Heal; Infected Wound; Wound Complication; Wound Dehiscence