Intrawound Vancomycin Powder in Spinal Fusion Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02631408

Acronym

iVRCT

Enrollment

308

Registered

2015-12-16

Start date

2015-08-31

Completion date

2021-03-01

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion Acquired

Keywords

spinal fusion, topical antibiotics, vancomycin, surgical site infection

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.

Interventions

DRUGVancomycin

Locally, intrawound applied vancomycin powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 10, 2026