Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02400112
Study type	Interventional
Source	University of Tennessee
Contact
Status	Terminated
Phase	Phase 4
Start date	March 2015
Completion date	October 2018

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