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Clinical Trial 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02631408
Study type Interventional
Source Orthopedic Hospital Vienna Speising
Contact
Status Completed
Phase Phase 4
Start date August 2015
Completion date March 1, 2021

See also
  Status Clinical Trial Phase
Completed NCT00808665 - Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion Phase 4
Recruiting NCT02466048 - Efficacy and Safety of SurgiFillâ„¢ on Spinal Fusion Phase 4