Intrawound Vancomycin Powder in Spinal Fusion Surgery

Phase 4

Completed

• Conditions: Spinal Fusion Acquired
• Interventions: Drug: Vancomycin

• Registration Number: NCT02631408
• Lead Sponsor: Orthopedic Hospital Vienna Speising

Brief 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

Detailed 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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-12
• Study First Submitted QC: 2015-12-12
• Study First Posted: 2015-12-16
• Primary Completion: 2019-03-01
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin Group	Vancomycin	Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged

Primary Outcome Measures

Name	Time	Method
SSI rate	1 year	Rate of superficial and deep surgical site infections (according to CDC criteria)

Secondary Outcome Measures

Name	Time	Method
Revision rate	1 year	Revision rate due to surgical site infections
C-reactive protein	7 days	Course of postoperative CRP levels

Trial Locations

Locations (1)

Orhopedic Hospital Speising; 🇦🇹 Vienna, Austria