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

Major Extremity Trauma Research Consortium

Status and phase: Enrolling; Phase 3

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

Treatments: Device: Incisional Negative Pressure Wound Therapy (NPWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06337292

IRB00440042

Details and patient eligibility

About

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. The secondary outcomes will independently assess the components of the primary outcome.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Standard of Care Wound Care

No Intervention group

Description:

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

Incisional Negative Pressure Wound Therapy (NPWT)

Experimental group

Description:

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

Treatment:

Device: Incisional Negative Pressure Wound Therapy (NPWT)