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

University of Tennessee

Status and phase: Terminated; Phase 4

Conditions: Fractures, Open; Surgical Wound Infection

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02400112

13-111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Vancomycin Powder

Experimental group

Description:

If the patient randomizes to the experimental group (vancomycin powder), the patient will receive open fracture care identical to the control group except that, prior to closure, 1 gram of vancomycin powder will be applied locally to the open fracture bed. The traumatic and surgical wounds will be closed over a sterile drain and dressed, and the extremity will be immobilized.

Treatment:

Drug: Vancomycin

Standard Treatment

No Intervention group

Description:

If the patient randomizes to the control group (standard treatment), the patient will receive irrigation and debridement of the fracture site and surrounding soft tissues. The fracture will then be stabilized in standard fashion determined by fracture personality. Once stabilized, a sterile drain will be placed in the open fracture bed and the traumatic and surgical wounds will be closed and dressed. The extremity will then be immobilized.