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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

Tracking Information
First Submitted Date  ICMJE December 12, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2015)
SSI rate [ Time Frame: 1 year ]
Rate of superficial and deep surgical site infections (according to CDC criteria)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02631408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • C-reactive protein [ Time Frame: 7 days ]
    Course of postoperative CRP levels
  • Revision rate [ Time Frame: 1 year ]
    Revision rate due to surgical site infections
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2015)
  • C-reactive protein [ Time Frame: 7 days ]
    Trend of postoperative CRP levels
  • Revision rate [ Time Frame: 1 year ]
    Revision rate due to surgical site infections
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrawound Vancomycin Powder in Spinal Fusion Surgery
Official Title  ICMJE Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Spinal Fusion Acquired
Intervention  ICMJE Drug: Vancomycin
Locally, intrawound applied vancomycin powder
Other Name: Vancomycin Hydrochloride, Powder for Solution for Infusion
Study Arms  ICMJE
  • 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
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 11, 2019)
308
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2015)
440
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02631408
Other Study ID Numbers  ICMJE iVRCT1_4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lukas Panzenboeck, Orthopedic Hospital Vienna Speising
Study Sponsor  ICMJE Orthopedic Hospital Vienna Speising
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philipp Becker, MD Orthopedic Hospital Speising
Study Chair: Lukas Panzenboeck, MD Orthopedic Hospital Speising
PRS Account Orthopedic Hospital Vienna Speising
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP