Clincosm LogoSign in Get a demo

iVRCT: Intrawound Vancomycin Powder in Spinal Fusion Surgery

Sponsor
Orthopedic Hospital Vienna Speising (Other)
Overall Status
Completed
CT.gov ID
NCT02631408
Collaborator
(none)
308
Enrollment
1
Location
2
Arms
67
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Aug 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SSI rate [1 year]

      Rate of superficial and deep surgical site infections (according to CDC criteria)

    Secondary Outcome Measures

    1. C-reactive protein [7 days]

      Course of postoperative CRP levels

    2. Revision rate [1 year]

      Revision rate due to surgical site infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orhopedic Hospital Speising Vienna Austria 1130

    Sponsors and Collaborators

    • Orthopedic Hospital Vienna Speising

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lukas Panzenboeck, Dr. Lukas Panzenboeck, Orthopedic Hospital Vienna Speising
    ClinicalTrials.gov Identifier:
    NCT02631408
    Other Study ID Numbers:
    • iVRCT1_4
    First Posted:
    Dec 16, 2015
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Lukas Panzenboeck, Dr. Lukas Panzenboeck, Orthopedic Hospital Vienna Speising
    spinal fusion
    topical antibiotics
    vancomycin
    surgical site infection
    Additional relevant MeSH terms:
    Surgical Wound Infection
    Vancomycin

    Study Results

    No Results Posted as of Mar 3, 2021