Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Status:
Withdrawn
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center