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

Primary Purpose

Surgical Site Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vancomycin powder
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vancomycin powder

Control

Arm Description

80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery.

80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 12, 2012
Last Updated
April 18, 2018
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01566422
Brief Title
Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Official Title
Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
unable to enroll any participants
Study Start Date
June 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin powder
Arm Type
Experimental
Arm Description
80 randomized patients will be given vancomycin powder in the surgical sites prior to closure following spinal surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
80 participants who were not randomized to receive Vancomycin powder will receive no intervention at the conclusion of their surgery.
Intervention Type
Drug
Intervention Name(s)
Vancomycin powder
Intervention Description
patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
Primary Outcome Measure Information:
Title
Determine efficacy of using local vancomycin powder
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16842714
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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PubMed Identifier
8539047
Citation
Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.
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PubMed Identifier
19651948
Citation
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PubMed Identifier
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Citation
Dahners LE, Funderburk CH. Gentamicin-loaded plaster of Paris as a treatment of experimental osteomyelitis in rabbits. Clin Orthop Relat Res. 1987 Jun;(219):278-82.
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PubMed Identifier
8981903
Citation
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Citation
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Citation
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Citation
O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, Devin CJ. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder. Spine J. 2011 Jul;11(7):641-6. doi: 10.1016/j.spinee.2011.04.025. Epub 2011 May 19.
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Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients

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