Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2022-06-01

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.

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Detailed Description

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Conditions

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Periprosthetic Joint Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants will not know which treatment arm they have been randomized to

Study Groups

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Sterile Water

Group Type EXPERIMENTAL

Sterile Water

Intervention Type OTHER

1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

3.5% betadine

Group Type EXPERIMENTAL

3.5% Betadine

Intervention Type OTHER

1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

0.05% chlorhexidine gluconate

Group Type EXPERIMENTAL

0.05% Chlorhexidine Gluconate

Intervention Type OTHER

1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

Interventions

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Sterile Water

1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

Intervention Type OTHER

3.5% Betadine

1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

Intervention Type OTHER

0.05% Chlorhexidine Gluconate

1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No