CompletedPhase 4

Intrawound Vancomycin Powder in Spinal Fusion Surgery

Austria308 participantsStarted 2015-08

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

SSI rate

Timeframe: 1 year

Trial details

NCT IDNCT02631408

SponsorOrthopedic Hospital Vienna Speising

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-01

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