Intrawound Vancomycin Powder in Spinal Fusion Surgery

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orthopedic Hospital Vienna Speising
• Treatments: Vancomycin

Criteria

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