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Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)

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ClinicalTrials.gov Identifier: NCT02631408
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : March 13, 2019
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02631408


Locations
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Austria
Orhopedic Hospital Speising
Vienna, Austria, 1130
Sponsors and Collaborators
Orthopedic Hospital Vienna Speising
Investigators
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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
ClinicalTrials.gov Identifier: NCT02631408     History of Changes
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
vancomycin
surgical site infection

Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents