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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Spinal Fusion Acquired trials