NCT06337292 · Major Extremity Trauma Research Consortium
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
(iVAC)
What this study is about
This is a multi-center, pragmatic, parallel treatment group$1 randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Incisional Negative Pressure Wound Therapy (NPWT)
Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and \>3cm in length.
Primary outcome measures
Complication composite outcome
Time frame: 3 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- The study injury is alread
Where
- Baltimore, Maryland
- Lebanon, New Hampshire
- Nashville, Tennessee
- Houston, Texas
- Falls Church, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations