Intrawound Vancomycin Powder in Spinal Fusion Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial

Conditions
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Spinal Fusion Acquired

Intervention / Treatment
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* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>No additional treatment. Routine iv. antibiotic prophylaxis only. | |
| Experimental: Vancomycin Group<br>Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged | Drug: Vancomycin<br>* Locally, intrawound applied vancomycin powder<br>* Other names: Vancomycin Hydrochloride, Powder for Solution for Infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI rate | Rate of superficial and deep surgical site infections (according to CDC criteria) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | Course of postoperative CRP levels | 7 days | 
| Revision rate | Revision rate due to surgical site infections | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal fusion, topical antibiotics, vancomycin, surgical site infection