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Incisional Negative Pressure Wound Therapy for High-Risk Fractures

This study is looking at whether a special wound dressing called Incisional Negative Pressure Wound Therapy (NPWT) can help reduce infections and other problems in people with certain high-risk leg fractures. You might be able to join if you are an adult with a high-risk fracture of the tibia (shin bone), specifically a tibial plateau, pilon, or open tibial shaft fracture that requires surgery. The study will compare Incisional NPWT to a standard wound dressing. Researchers will look at how well your wound heals and if you have complications within 3 months. The study plans to enroll 352 people, but its current recruitment status is unclear.

Study design
This is a multi-center randomized controlled trial, meaning participants are randomly assigned to one of two groups. It plans to enroll 352 patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your clinical status will be evaluated 3 months after you are assigned to a treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06337292

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Major Extremity Trauma Research Consortium
~352 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Incisional Negative Pressure Wound Therapy (NPWT)

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complication composite outcome
Measured over 3 months

Conditions

Fracture of Tibia
Wound Heal
Infected Wound
Wound Complication
Wound Dehiscence

Explore related trials

Tibia Fracture

Where it's being run

6 sites across 5 states
Maryland2
New Hampshire1
Tennessee1
Texas1
Virginia1

Study leadership

  • I. Leah Gitajn, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center
  • Renan Castillor, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health

Who to contact

Leah Gitajn, MD
[email protected]
603-650-5133
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

  • Complication composite outcome3 months

    The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale