Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty

Study Overview
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Brief Summary
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The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.

Detailed Description
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Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation. Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.

Official Title
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Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis, Avascular Necrosis of Hip

Intervention / Treatment
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* Procedure: 1.0 g Vancomycin powder into the wound
* Procedure: 0,35% povidone-iodine solution lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening Exclusion Criteria: Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0,35% povidone-iodine solution lavage<br>0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation. | Procedure: 0,35% povidone-iodine solution lavage<br>* 0,35% povidone-iodine solution lavage left for 3 minutes following final implantation<br>|
| Experimental: 1.0 g Vancomycin powder into the wound<br>additional 1.0 g Vancomycin powder into the wound | Procedure: 1.0 g Vancomycin powder into the wound<br>* 0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprosthetic joint infection | infection rate in each group | 90 days |