Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Not Applicable

Terminated

• Conditions: Periprosthetic Joint Infection
• Interventions: Other: 0.05% Chlorhexidine Gluconate; Other: 3.5% Betadine; Other: Sterile Water

• Registration Number: NCT04274517
• Lead Sponsor: University of Southern California

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-18
• Study Start: 2021-01-16
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.05% chlorhexidine gluconate	0.05% Chlorhexidine Gluconate	-
3.5% betadine	3.5% Betadine	-
Sterile Water	Sterile Water	-

Primary Outcome Measures

Name	Time	Method
Microbial Contamination Rate of Surgical Instruments	14 days	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

Secondary Outcome Measures

Name	Time	Method
90-Day Wound Complication	90 days	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

Trial Locations

Locations (1)

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States