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.

NCT Number	NCT06337292
Lead Sponsor	Major Extremity Trauma Research Consortium
Conditions	Fracture of Tibia, Wound Heal, Infected Wound, Wound Complication, Wound Dehiscence
Enrollment	352 participants
Start Date	2025-01-01
Primary Completion	2028-09-30 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-12