Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

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

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.

Study Overview

• Status: Terminated
• Conditions: Periprosthetic Joint Infection
• Intervention / Treatment: Other: Sterile Water; Other: 3.5% Betadine; Other: 0.05% Chlorhexidine Gluconate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California

Publications and helpful links

General Publications

• Anto B, McCabe J, Kelly S, Morris S, Rynn L, Corbett-Feeney G. Splash basin bacterial contamination during elective arthroplasty. J Infect. 2006 Mar;52(3):231-2. doi: 10.1016/j.jinf.2005.06.013. Epub 2005 Dec 28. No abstract available.
• Baird RA, Nickel FR, Thrupp LD, Rucker S, Hawkins B. Splash basin contamination in orthopaedic surgery. Clin Orthop Relat Res. 1984 Jul-Aug;(187):129-33.
• Frisch NB, Kadri OM, Tenbrunsel T, Abdul-Hak A, Qatu M, Davis JJ. Intraoperative chlorhexidine irrigation to prevent infection in total hip and knee arthroplasty. Arthroplast Today. 2017 May 12;3(4):294-297. doi: 10.1016/j.artd.2017.03.005. eCollection 2017 Dec.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2021
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 18, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Povidone-Iodine; Chlorhexidine gluconate
• Other Study ID Numbers: HS-19-01005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes