Sextant: Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures
Abstract
Infection remains the most common and significant complication following high-energy open fractures, with rates ranging from 15-40%. Up to 15% of recent combat casualties develop osteomyelitis. At present, antibiotics are delivered in an empiric fashion, as the surgeon does not know the bacterial profile of the open fracture wound at the time of injury or at the time of wound coverage/closure. Building on conclusions from a prospective observational study that evaluated the bioburden of severe lower extremity wounds sampled at the time of final woundcoverage or closure, this project will study the impact of a new antibiotic delivery treatment strategy compared to the existing standard of care antibiotic prophylaxis strategy to evaluate the impact on deep SSI. Objective. The overall objective of the proposed study is to perform a PRCT in order to compare the antibiotic and infection related outcomes of a new antibiotic strategy for use in the care of severe open extremity fractures to the current standard of care. Study Design. This study will be conducted in 30 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 or 2) experimental protocol (SEXTANT) that will direct a wound bioburden targeted systemic and topical vancomycin powder and tobramycin powder antibiotic treatment at the time of final wound closure/coverage. The study will compare results of the current SOC prophylactic coverage to the SEXTANT protocol. As of 9/30/21, 2 participants have been enrolled in the study; 1 randomized in control and 1 randomized in treatment arm. There are three sites actively screening and other participating sites status can be found in the attachment.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1161286
Entities
People
- Michael Bosse
Organizations
- Atrium Health