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

NCT ID: NCT06337292

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Wound Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Incisional Negative Pressure Wound Therapy (NPWT)

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Major Extremity Trauma Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I. Leah Gitajn, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Renan Castillor, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leah Gitajn, MD

Role: CONTACT

ida.leah.gitajn@hitchcock.org

603-650-5133

Other Identifiers

IRB00440042

Identifier Type: -

Identifier Source: org_study_id