Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2023

Interventions

  • Other: Sterile Water
    • 1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
  • Other: 3.5% Betadine
    • 1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
  • Other: 0.05% Chlorhexidine Gluconate
    • 1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.

Arms, Groups and Cohorts

  • Experimental: Sterile Water
  • Experimental: 3.5% betadine
  • Experimental: 0.05% chlorhexidine gluconate

Clinical Trial Outcome Measures

Primary Measures

  • Microbial Contamination Rate of Surgical Instruments
    • Time Frame: 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 Measures

  • 90-Day Wound Complication
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Southern California
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nathanael Heckmann, Assistant Professor of Clinical Orthopaedic Surgery – University of Southern California
  • Overall Contact(s)
    • Nathanael Heckmann, MD, 323-442-5762, nh70333@usc.edu

References

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. Epub 2005 Dec 28.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.