Not Yet RecruitingPhase 4ACTRN12626000076370

TRIAD: Trial for Reducing Infection After Arthroplasty with Dilute Povidone-Iodine

Trial for Reducing Infection After Arthroplasty with Dilute Povidone-Iodine in end-stage arthritis patients, with the primary outcome being a validated diagnosis of surgical site infection (SSI) at 3 months post-surgery.

Sponsor

Australian National University

Enrollment

5,460 participants

Start Date

Jun 30, 2026

Study Type

Interventional

Conditions

End Stage Arthritis Osteoarthritis Total Knee Replacement

Summary

Trial for Reducing Infection After Arthroplasty with Dilute povidone-iodine lavage (TRIAD) is a multi-centre, AOANJRR-nested, cluster randomised trial utilising a hospital-level crossover design that will provide pragmatic low bias world class clinical evidence on the unmet need of surgical site infection (SSI) reduction following hip and knee arthroplasty surgery. It will compare pre-closure lavage with dilute povidone-iodine lavage to normal saline only lavage to reduce bacterial surgical site contamination. This intra-operative bacterial decontamination method if effective, is low cost, low risk and universally available to Australian orthopaedic surgeons. Currently, healthcare professionals have few scientifically validated methods to reduce the risk of SSI following arthroplasty surgery and TRIAD would provide an avenue for establishing this as a standard of care at an international level for reduction of infection following hip/knee arthroplasty. The primary objective of this study is to evaluate the efficacy of dilute betadine lavage in reducing surgical site infections (SSI) occurring within 90 days in adults undergoing primary, elective THA or TKA for osteoarthritis (OA).

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

All patients (aged >=18 years) undergoing primary Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA) for osteoarthritis

Exclusion Criteria5

Undergoing primary hip or knee arthroplasty for indications other than primary osteoarthritis (including neck of femur fracture, inflammatory arthropathy, or avascular necrosis)
Scheduled for revision THA or TKA
Procedures involving concomitant removal of metal
Patients with a contraindication to the intervention, such as a documented allergy to povidone-iodine (PI) or related iodinated products
Patients unable to commit to a minimum of 12 months of clinical follow-up.

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Interventions

- 0.35% dilute povidone-iodine lavage for 3 minutes prior to wound closure + 10% povidone iodine administered to skin edges prior to closure - Adherence to the allocated intervention (dilute PI lavag

- 0.35% dilute povidone-iodine lavage for 3 minutes prior to wound closure + 10% povidone iodine administered to skin edges prior to closure - Adherence to the allocated intervention (dilute PI lavage or saline lavage) will be monitored based on effective administration of the allocated intervention. Deviations from the allocated intervention (dilute PI lavage or saline lavage) may occur in the event of an adverse intraoperative event, supply issues or late identified contraindication by the treating surgical team; these instances will be documented.