NCT06337292

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture of Tibia
• Wound Heal
• Infected Wound
• Wound Complication
• Wound Dehiscence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-09-30
• Completion: 2028-12-31
• First posted: 2024-03-29
• Last updated: 2025-05-02

Locations

2 sites across 1 country: United States