Novel Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: Tobra - A Multicenter RCT
Abstract
This study will build upon the success of the VANCO study (Contract Number: W81XWH-10-2-0134, FDA IND #119891) which enrolled 980 patients into a randomized controlled trial investigating topical Vancomycin powder versus no powder in patients having plate and screw fixation for fractures at risk of surgical site infection. The PI, Co-PI and most of the research team that led the VANCO study will serve similar roles in the current study. The proposed study design is a pragmatic, prospective, randomized controlled trial comparing deep surgical site infection rates in patients treated with either local Vancomycin powder or local Vancomycin and Tobramycin powders at the time of fracture fixation (in addition to standard of care). This study design will provide the highest quality evidence to investigate our hypothesis that the use of local Vancomycin and Tobramycin powders will be effective at decreasing deep surgical site infection in these at-risk patients. Participants (950 per treatment arm) will be enrolled from METRC trauma centers over a 24-month period and followed for 12 months following definitive fracture fixation surgery. Participants will be recruited during hospitalization for the initial injury.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 30, 2020
- Accession Number
- AD1125473
Entities
People
- Robert V. O'toole
Organizations
- University of Maryland, Baltimore