Overview

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

Status:
Terminated
Trial end date:
2018-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Tennessee
Treatments:
Vancomycin
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