Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
Surgical site infections (SSI) are not uncommon, especially in specific high-risk groups
including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized
measures have been adopted to reduce surgical site infection, and the use of topical
vancomycin powder has gained popularity in recent years. Given the lack of high-quality
evidence for the use of topical vancomycin to reduce surgical site infections in open
posterior spine surgery, which is currently the most common approach to spine surgery, it is
crucial to study the use of vancomycin powder in reducing surgical site infections. This
study is a prospective, single-blinded open label randomized controlled trial, with one arm
of patients having local administration of 1g vancomycin powder which will be placed in the
deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic
surgeon, whereas the control arm will be without such application of vancomycin. Both arms of
patients will still be undergoing the same operation procedures, as well as postoperative
local wound drainage and wound care. This study will provide insights on the reduction rate
in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of
using topical vancomycin in reducing surgical site infection between different disease
groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These
proposed findings will provide valuable information for clinicians and institutions on future
measures for surgical site infection of open posterior spine surgery.