Recruiting
Phase 3

Negative Pressure Wound Therapy

Sponsor:

Major Extremity Trauma Research Consortium

Code:

NCT06337292

Conditions

Fracture of Tibia

Wound Heal

Infected Wound

Wound Complication

Wound Dehiscence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Incisional Negative Pressure Wound Therapy (NPWT)

Study Details

Brief summary:

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.

Conditions

Fracture of Tibia

Wound Heal

Infected Wound

Wound Complication

Wound Dehiscence

Study ID

NCT06337292

Start date

Jan 1, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Wound Care

Patients randomized to the control group will receive standard wound care.

experimental: Incisional Negative Pressure Wound Therapy (NPWT)

Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum.

Interventions

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 measure

  • Complication composite outcome [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland R Adams Cowley Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Robert O'Toole, MD

University of Maryland Shock Trauma/Capitol Regions

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Leah Gitajn, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

UTHealth/McGovern Medical School

Recruiting

Houston, Texas, United States, 77030

Contacts

Inova Fairfax MEdical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2026-05-12.