Topical Vancomycin for Infection Prophylaxis in TJA
Status:
Not yet recruiting
Trial end date:
2025-06-15
Target enrollment:
Participant gender:
Summary
11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7%
undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026.
Periprosthetic joint infection (PJI) remains one of the most common complications, accounting
for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the
incidence of PJI but its potential drawbacks include wound healing complications, reduced
osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical
administration of vancomycin powder for the primary prevention of PJI has been studied in
observational studies, but conclusions are limited due to the low incidence of PJI and high
number of patients required to detect a significant difference. Investigators therefore
propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin
compared to standard care on PJI rates following THA and TKA.
Aim: To determine whether topical vancomycin is a safe and effective intervention for the
primary prevention of PJI after THA and TKA.
Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess
feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50
TKA patients.
Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year
follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis,
post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history
or synovial aspirate Prior major operation on the affected joint Current immunosuppressive
medications Vancomycin allergy or history of a vancomycin-related complication Recruitment:
surgeons introduce study to the patients, research staff will conduct recruitment.
Intervention: Patients will be randomized preoperatively and remain blinded to their
treatment arm. Patients allocated to the control group will have all standard care infection
prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the
standard care measures in addition to 1g of powdered vancomycin applied to the wound.
Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1
year visits.
Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups:
Reoperation on the same joint Superficial and non-infectious wound complications All
complications