Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
- Registration Number
- NCT03705962
- Lead Sponsor
- University of Virginia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibiotic Tobramycin Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
- Primary Outcome Measures
Name Time Method Presence of Wound Infection 6 weeks post op Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States