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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ida.leah.gitajn@hitchcock.org
• Phone: 603-650-5133

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.