NCT03839914

Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

Recruiting now NA Last updated 4 December 2024

What this trial tests

NA trial testing Vancomycin powder in Spinal Deformity in 76 participants. Currently enrolling.

Timeline

1 August 2020

Primary endpoint
31 December 2025

31 March 2026

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	76
Start date	1 August 2020
Primary completion	31 December 2025
Estimated completion	31 March 2026
Sites	1 location across Hong Kong

Drugs / interventions tested

• Vancomycin powder

Conditions studied

• Spinal Deformity — all drugs for Spinal Deformity →
• Trauma — all drugs for Trauma →
• Spinal Tumor — all drugs for Spinal Tumor →
• Surgical Site Infection — all drugs for Surgical Site Infection →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Spinal Deformity or Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.