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Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02631408
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Lukas Panzenboeck, Orthopedic Hospital Vienna Speising

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Spinal Fusion Acquired Drug: Vancomycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

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 Name: Vancomycin Hydrochloride, Powder for Solution for Infusion

Primary Outcome Measures :
  1. SSI rate [ Time Frame: 1 year ]
    Rate of superficial and deep surgical site infections (according to CDC criteria)

Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: 7 days ]
    Course of postoperative CRP levels

  2. Revision rate [ Time Frame: 1 year ]
    Revision rate due to surgical site infections

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02631408

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Orhopedic Hospital Speising
Vienna, Austria, 1130
Sponsors and Collaborators
Orthopedic Hospital Vienna Speising
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Principal Investigator: Philipp Becker, MD Orthopedic Hospital Speising
Study Chair: Lukas Panzenboeck, MD Orthopedic Hospital Speising

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Responsible Party: Lukas Panzenboeck, Dr. Lukas Panzenboeck, Orthopedic Hospital Vienna Speising Identifier: NCT02631408    
Other Study ID Numbers: iVRCT1_4
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Lukas Panzenboeck, Orthopedic Hospital Vienna Speising:
spinal fusion
topical antibiotics
surgical site infection
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents