Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Periprosthetic Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04274517
• Other study ID #: HS-19-01005
• Status: Terminated
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periprosthetic Joint Infection

Intervention

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

Locations

Country	Name	City	State
United States	Keck School of Medicine of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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