Fractures, Open, Surgical Wound Infection
Conditions
Keywords
Vancomycin
Brief summary
The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.
Detailed description
Hypothesis: Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm. Methods: Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment. Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.
Interventions
DRUGVancomycin
Vancomycin powder administered locally, intraoperatively at site of open fracture
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Skeletally mature patients ≥18 years of age * Acute Gustilo-Anderson Type I-IIIA open fracture * Fracture is deemed primarily closable at initial surgery * Likely to follow-up with surgeon until fracture is healed * Ability to understand and agree to Informed Consent
Exclusion criteria
* Patients \<18 years of age * Gustilo-Anderson Type IIIB and IIIC open fractures * Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects) * Delayed presentation of open fracture * Pre-existing systemic infection requiring antibiotic therapy * Allergy to Vancomycin * Open fracture at the site of a previous fracture or surgical site * Current skin infection, chronic wounds or known systemic infection * Unlikely to follow-up until fracture is healed * Unable to understand or agree to Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Infection | one year | Infections will be considered clinically significant if they require a return to the operating suite for surgical debridement. These infections will be classified as acute infections and/or chronic osteomyelitis. Superficial skin infections will be treated with local wound care, oral antibiotics and incision and drainage (as indicated). Deep infections and chronic osteomyelitis will be treated with staged serial surgical debridement, hardware removal (as indicated), culture specific IV antibiotics, and Infectious Disease consultation. |
Countries
United States
Outcome results
None listed