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Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients

NCT01566422 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Vancomycin powder

patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566422 on ClinicalTrials.gov