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

NCT06337292 | Recruiting Phase 3

• 1 other identifier: IRB00440042
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Complication composite outcome

  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

  3 months

Study Arms (2)

Standard of Care Wound Care

NO INTERVENTION

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

Incisional Negative Pressure Wound Therapy (NPWT)

EXPERIMENTAL

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

Device: Incisional Negative Pressure Wound Therapy (NPWT)

Interventions

Incisional Negative Pressure Wound Therapy (NPWT) 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.

Incisional Negative Pressure Wound Therapy (NPWT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Requiring incision for fixation or debridement of 3 cm or greater.
• Patients 18 years of age or older

You may not qualify if:

• The study injury is already infected at time of study enrollment.
• Patient is unable to receive incisional NPWT for any reason.
• Patients who have already had definitive fixation prior to enrollment in the study.
• 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).
• The study injury is a Gustilo Type IIIB or IIIC open fracture.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (2)

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures; Wound Infection

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Infections

Study Officials

• I. Leah Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Renan Castillor, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Gitajn, MD

CONTACT

603-650-5133; ida.leah.gitajn@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)