Clinical trial NCT02631408: Intrawound Vancomycin Powder in Spinal Fusion Surgery
Official title: Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Fusion Acquired
Keywords: spinal fusion
topical antibiotics
vancomycin
surgical site infection
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: SSI rate
timeFrame: 1 year
Secondary outcomes:
measure: C-reactive protein
timeFrame: 7 days
measure: Revision rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orhopedic Hospital Speising
Study officials:
affiliation: Orthopedic Hospital Speising
name: Philipp Becker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic Hospital Speising
name: Lukas Panzenboeck, MD
role: STUDY_CHAIR
References: