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Recruiting NCT06337292

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

Phase III Interventional Fracture of Tibia Wound Heal Infected Wound Wound Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Incisional Negative Pressure Wound Therapy (NPWT).
Who it may be relevant to
Registry conditions: Fracture of Tibia, Wound Heal, Infected Wound, Wound Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device 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 measures

  • Complication composite outcome [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • University of Maryland R Adams Cowley Shock Trauma Center — Baltimore
  • University of Maryland Shock Trauma/Capitol Regions — Baltimore
  • Dartmouth-Hitchcock Medical Center — Lebanon
  • Vanderbilt University — Nashville
  • UTHealth/McGovern Medical School — Houston
  • Inova Fairfax MEdical Campus — Falls Church

Identifiers

NCT: NCT06337292 · IRB00440042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗