Clinical trial NCT02400112: Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
Official title: Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fractures, Open
Surgical Wound Infection
Keywords: Vancomycin
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Postoperative Infection
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga/Erlanger Health System
name: Dirk W Kiner, MD
role: PRINCIPAL_INVESTIGATOR
References: