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.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Data sourced from ClinicalTrials.gov