Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)

March 2, 2021 updated by: Lukas Panzenboeck, Orthopedic Hospital Vienna Speising

Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial

Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in spinal fusion surgery. The powder will be locally administered into to the wound cavity before wound closure.

Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical site infections

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vancomycin is being widely used as an antibiotic agent for intravenous and topical use. The surgical application of vancomycin powder in Austria is limited as there is no powder with marketing authorization for intraoperative, intrawound usage. Previous reports widely document the application of vancomycin powder for solution for infusion. The powder is not soluted, but instead directly spread throughout the wound surface. Limited data is available for spinal fusion surgery, mostly retrospective studies. Results were promising, but the low evidence level does not allow for a conclusion regarding routine usage. Additional randomized, controlled trials are necessary to further investigate this matter.

This trial aims to investigate Vancomycin powder "Xellia" 1000mg, which has a Marketing authorization, in an off-label usage (intrawound, intraoperatively) in spinal fusion surgery. The investigational medicinal product will be used unmodified.

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1130
        • Orhopedic Hospital Speising

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned TLIF (transforaminal lumbar interbody fusion) or PLIF (posterolateral lumbar interbody fusion) surgery
  • TLIF/PLIF fusion length of one or two motion-segments OR
  • One motion-segment TLIF/PLIF in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy)
  • Fusions within L1 (first lumbar vertebra) through S1 (sacrum)
  • Age of 18-years or older
  • Signed informed consent

Exclusion Criteria:

  • Preoperative inflammatory or infectious state (C-reactive protein levels above 10mg/l)
  • Allergic to vancomycin, teicoplanin or penicillin
  • Preexisting auto-immune disease with an impaired immune system
  • Current post-traumatic vertebral injury (e.g. vertebral split fracture)
  • Preexisting Renal impairment
  • Preexisting cochlea damage
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No additional treatment. Routine iv. antibiotic prophylaxis only.
Experimental: Vancomycin Group
Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged
Drug: Vancomycin
Locally, intrawound applied vancomycin powder
Other Names:
  • Vancomycin Hydrochloride, Powder for Solution for Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSI rate
Time Frame: 1 year
Rate of superficial and deep surgical site infections (according to CDC criteria)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: 7 days
Course of postoperative CRP levels
7 days
Revision rate
Time Frame: 1 year
Revision rate due to surgical site infections
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopedic Hospital Vienna Speising

Investigators

  • Principal Investigator: Philipp Becker, MD, Orthopedic Hospital Speising
  • Study Chair: Lukas Panzenboeck, MD, Orthopedic Hospital Speising

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

December 12, 2015

First Submitted That Met QC Criteria

December 12, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iVRCT1_4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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