Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)

Orthopedic Hospital Vienna Speising

Status and phase

Completed

Phase 4

Conditions

Spinal Fusion Acquired

Treatments

Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT02631408

iVRCT1_4

Details and patient eligibility

About

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

Full 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.

Enrollment

308 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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