Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

18088

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.

2015-07-01

2019-03-07

2019-03-07

Terminated

Early phase I

11

Inclusion Criteria: * Ages 18 - 70 years * Gustilo Type I,II,IIIa open fracture (s) * Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated) * Subject should be able to follow up at the scheduled times following surgery * Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study Exclusion Criteria: * Closed fracture * Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively) * Aminoglycoside allergy * Presentation greater than 48 hours after injury * Pathologic fracture * Preexisting infection in bone with an open fracture * Patients with multiple trauma involving liver, kidney, or brain * Pregnancy (self-reported) * Current status as prisoner

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-06-15