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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Vancomycin powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All English-speaking patients ≥ 18 years undergoing posterior spine fusions at Vanderbilt University Medical Center for the treatment of traumatic injuries will be considered for inclusion Exclusion Criteria have a known allergy to vancomycin do not agree to participate had previous spine surgery at the injury level within 6 months are pregnant have a history of Steven's Johnson Syndrome have a history of infections at the surgical site have a history of cancer or radiation treatment at the injured level have open spine fractures have traumatic injuries to non-spine organ systems that limit their functional capacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin powder<br>80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery. | Drug: Vancomycin powder<br>* patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.<br>|
| No Intervention: Control<br>80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine efficacy of using local vancomycin powder | 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). | 2 years |