Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chattanooga, Tennessee 37403


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02400112


Primary Contact:

Principal Investigator
Dirk W Kiner, MD
University of Tennessee College of Medicine Chattanooga/Erlanger Health System


Backup Contact:

N/A


Location Contact:

Chattanooga, Tennessee 37403
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.