Topical Vancomycin for Infection Prophylaxis in TJA

NCT04993027 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: REB21-0490
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Infection of Total Hip Joint Prosthesis; Infection of Total Knee Joint Prosthesis

Outcome Measures

Primary Outcomes (3)

• Rate of Periprosthetic Joint Infection in the same joint

  Peri-operative Joint Infection in the operated joint

  at six weeks post-operative.

• Rate of Periprosthetic Joint Infection in the same joint

  Peri-operative Joint Infection in the operated joint

  at three months post-operative.

• Rate of Periprosthetic Joint Infection in the same joint

  Peri-operative Joint Infection in the operated joint

  at one year post-operative.

Secondary Outcomes (9)

• Rate of reoperation

  at six weeks post-operative.

• Rate of reoperation

  at three months post-operative.

• Rate of reoperation

  at one year post-operative.

• Rate of superficial and non-infectious wound complications

  at six weeks post-operative.

• Rate of superficial and non-infectious wound complications

  at three months post-operative.

Study Arms (2)

Vancomycin Group:

EXPERIMENTAL

patients will have single dose of 1g vancomycin powder placed on their incision during surgery in addition to: pre- and post-operative intravenous antibiotic administration, sterile surgical helmet systems, saline pulse lavage irrigation, and antimicrobial drapes.

Drug: Vancomycin Powder

Control Group

NO INTERVENTION

pre- and post-operative intravenous antibiotic administration, sterile surgical helmet systems, saline pulse lavage irrigation, and antimicrobial drapes.

Interventions

Vancomycin Powder DRUG

Vancomycin is a bactericidal aminoglycoside antibiotic which inhibits cell wall synthesis. It is effective against gram positive bacteria. Though most commonly administered intravenously, it can be delivered orally or directly into surgical incisions and wounds in certain indications.

Also known as: Vancomycin Hydrochloride

Vancomycin Group:

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older, who are undergoing elective primary THA or TKA for osteoarthritis
• Patients must be able and willing to complete one year of follow-up postoperatively

You may not qualify if:

• 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 including osteotomy, open reduction internal fixation, or major open ligamentous repair, but excluding arthroscopic procedures such as ACL reconstruction or meniscus or labral debridement/repair
• Current immunosuppressive medications
• Vancomycin allergy or history of a vancomycin-related complication such as ototoxicity or nephrotoxicity

Sponsors & Collaborators

• Alberta Hip and Knee Clinic: lead
• University of Calgary: collaborator

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nicholas Desy, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Desy, MD

CONTACT

4034047212; nicholas.desy@albertahealthservicecs.ca

Teresa HL Nguyen, BSc

CONTACT

4035873725; thlnguye@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: August 6, 2021
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share