drugset / Trial / NCT03883022

Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery

NCT03883022 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.

Timeline

Start
2018-09-03
Primary completion
2027-09-12
Completion
2027-12-31

Outcome

Met primary endpoint

paper There were no DSSIs in the vancomycin group and five in the control group (0 vs 1.4%, p=.029). PMID 40334989 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 1 g Other
Subject Vancomycin Other / unclassified 2 g Other