RecruitingPhase 3NCT06337292

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

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

Sponsor

Major Extremity Trauma Research Consortium

Enrollment

352 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Wound Heal Wound Complication Wound Dehiscence Fracture of Tibia infected wound

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Incisional Negative Pressure Wound Therapy (NPWT) for people with fracture of tibia, wound complication, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIncisional 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.