Possibia

6337292

Last Update Posted: 2025-05-02

Recruiting

All Genders

accepted

18 Years +

352 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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. The secondary outcomes will independently assess the components of the primary outcome.

Eligibility

Relevant conditions:

Fracture of Tibia

Wound Heal

Infected Wound

Wound Complication

Wound Dehiscence

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

Data sourced from ClinicalTrials.gov