Status:
RECRUITING
Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients
Lead Sponsor:
The University of Hong Kong
Conditions:
Spinal Deformity
Trauma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 bee...
Detailed Description
Objectives: Primary Objectives: To evaluate the efficacy of intra-wound administration of vancomycin powder as add-on prophylactic intraoperative antibiotic in patients at high risk for surgical sit...
Eligibility Criteria
Inclusion
- Female or male adult with age ≥18 years
- Undergoing open posterior spinal surgery with instrumentation indicated for spinal deformity, trauma and tumor
- Able to understand the nature, scope and possible consequences of participation in the study
- Appropriate voluntary written informed consent have been provided by patients
Exclusion
- Has been treated with antibiotics due to primary spinal infection (i.e. spondylodiscitis) within 1 year prior to surgery
- Ongoing treatment with antibiotics for other infections
- Undergoing minimally invasive surgery or anterior-only surgical approaches or deformity correction surgery for adolescent idiopathic scoliosis (inherent low-risk for surgical site infections18)
- Undergoing decompression-only surgery for cervical spine, spinal deformity, trauma and tumors
- Has known history of allergy to vancomycin, penicillin and other glycopeptides (teicoplanin)
- Has history of vancomycin resistance
- Pregnancy
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03839914
Start Date
August 1 2020
End Date
March 31 2026
Last Update
December 4 2024
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong