Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Study Overview
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Brief Summary
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The usage of splash basins in the setting of total knee arthroplasty and total hip arthroplasty presents a risk of contamination and subsequent periprosthetic joint infection. Previous studies have investigated the efficacy of multiple antimicrobial irrigants for preventing periprosthetic joint infection, but the results are varied. Despite several noteworthy studies on the appropriate usage of different antiseptic solutions in surgical splash basins, the current literature has several limitations. First, there are no head-to-head clinical trials comparing betadine and chlorhexidine gluconate (CHG) usage with relation to periprosthetic joint infection and splash basin contamination rates. Second, the in vitro studies directly cultured splash basin antiseptic solutions rather than culturing surgical instruments. The objective of this study is to compare the microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG. The overall purpose of the study is to investigate the efficacy of 0.05% CHG and determine if it is an appropriate solution to use in surgical splash basins for joint replacement surgeries. A prospective clinical trial will be conducted. Patients treated at the Keck Hospital of USC or USC Verdugo Hills Hospital for primary total hip or total knee arthroplasty will be screened for inclusion in our study. All primary surgeries will be performed according to the preferences of the operating surgeon. No deviations from standard surgical care will be made based on inclusion in this study. However, prior to surgery, patients who elect to participate will be randomized to one of three groups: (1) sterile water, (2) 3.5% betadine, or (3) 0.05% CHG.

Official Title
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The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial

Conditions
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Periprosthetic Joint Infection

Intervention / Treatment
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* Other: Sterile Water
* Other: 3.5% Betadine
* Other: 0.05% Chlorhexidine Gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty. Exclusion Criteria: Age < 18 years. History of previous total hip arthroplasty or total knee arthroplasty. History of previous knee or hip joint infection. History of previous allergic reaction to chlorhexidine. Known allergy to iodine or shellfish.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterile Water<br> | Other: Sterile Water<br>* 1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.<br>|
| Experimental: 3.5% betadine<br> | Other: 3.5% Betadine<br>* 1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.<br>|
| Experimental: 0.05% chlorhexidine gluconate<br> | Other: 0.05% Chlorhexidine Gluconate<br>* 1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial Contamination Rate of Surgical Instruments | Microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-Day Wound Complication | Differences in 90-day wound complications and 90-day periprosthetic joint infections between the sterile water, 3.5% betadine, and 0.05% CHG surgical splash basin groups | 90 days |