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RECRUITING
NCT06337292
PHASE3

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

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2025-01-01

Completion Date

2028-12-31

Last Updated

2025-05-02

Healthy Volunteers

No

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.

Locations (2)

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States