Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2018 |
| Start Date: | March 2015 |
| End Date: | October 2018 |
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.
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.
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.
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.
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
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