Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious concern. The incidence of deep infection after spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of treating such infections is profound. With diminishing healthcare dollars and policy that refuses to reimburse for postoperative infections, it is critical that physicians and hospital systems seek out cost effective ways of decreasing postoperative infections. Local delivery of antibiotics into the surgical site have been found to significantly decrease infection rates in those undergoing posterior spine fusion for traumatic injuries as studied in a retrospective manner by the investigators of this grant. In this proposal the investigators will prospectively randomize patients undergoing posterior spinal stabilization for traumatic injuries into either receiving vancomycin powder into the surgical site (treatment) versus not receiving vancomycin powder (control) and subsequently follow infection rate, complications, and cost of care. The investigator's hypothesis is that i) vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a cost saving advancement in the safety of delivering spine surgical care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients|
- Determine efficacy of using local vancomycin powder [ Time Frame: 2 years ] [ Designated as safety issue: No ]Patient demographics and perioperative information obtained will include: comorbidities known to increase the risk of infection, body mass index, level of injury, presence of neurologic deficit, prealbumin level, evidence of an open fracture elsewhere, injury severity score, operative time, estimated blood loss, and blood creatinine levels. All wounds will be assessed 4-6 weeks after surgery to address early surgical site infection (SSI).
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Vancomycin powder
80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery.
Drug: Vancomycin powder
patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
No Intervention: Control
80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566422
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Sheyan J Armaghani, MD 352-318-3235 firstname.lastname@example.org|
|Principal Investigator: Sheyan J Armaghani, MD|