Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    270
  • sponsor
    University of Southern California
Updated on 25 March 2022

Summary

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.

Details
Condition Periprosthetic Joint Infection
Treatment Sterile water, 3.5% Betadine, 0.05% Chlorhexidine Gluconate
Clinical Study IdentifierNCT04274517
SponsorUniversity of Southern California
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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