Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06337292

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Complication composite outcome

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Gitajn, MD

CONTACT

[email protected]

603-650-5133

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Registry information

Official study title

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

Acronym: iVAC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 29, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.