Condition: Post Operative Surgical Site Infection · Sponsor: Major Extremity Trauma Research Consortium
The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers. The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol. Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includ…
This description comes directly from the study's public registry record.
Suna Chung, MPH · 4105023357 · schung60@jhu.edu
Susan C Collins, MSc · 410-502-8966 · scolli21@jhu.edu
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| Stanford University | Redwood City, California, United States | Recruiting |
| _University of California, San Francisco | San Francisco, California, United States | Recruiting |
| University of California at San Francisco | San Francisco, California, United States | Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| St Mary's University/Tenent Health | West Palm Beach, Florida, United States | Recruiting |
| Emory University School of Medicine | Atlanta, Georgia, United States | Recruiting |
| Indiana University School of Medicine - Methodist Hospital | Indianapolis, Indiana, United States | Recruiting |
| Indiana University/Eskenazi Health | Indianapolis, Indiana, United States | Recruiting |
| University of Kentucky | Lexington, Kentucky, United States | Recruiting |
| LSU Health Sciences | New Orleans, Louisiana, United States | Recruiting |
| University of Maryland , MD Department of Orthopaedics | Baltimore, Maryland, United States | Recruiting |
| Walter Reed Military Medical Center | Bethesda, Maryland, United States | Recruiting |
+ 19 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04678154