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

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. 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

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Study Overview

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Study Details

Study overview

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.

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

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

Condition
Fracture of Tibia
Intervention / Treatment

-

Contacts and Locations

Baltimore

University of Maryland R Adams Cowley Shock Trauma Center, Baltimore, Maryland, United States, 21201

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Major Extremity Trauma Research Consortium,

I. Leah Gitajn, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Renan Castillor, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

2028-12-31