Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

NCT04274517 | Terminated

• 1 other identifier: HS-19-01005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 90-Day Wound Complication

  90 days

Study Arms (3)

Sterile Water

EXPERIMENTAL

Other: Sterile Water

3.5% betadine

EXPERIMENTAL

Other: 3.5% Betadine

0.05% chlorhexidine gluconate

EXPERIMENTAL

Other: 0.05% Chlorhexidine Gluconate

Interventions

Sterile Water OTHER

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

Sterile Water

3.5% Betadine OTHER

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

3.5% betadine

0.05% Chlorhexidine Gluconate OTHER

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

0.05% chlorhexidine gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting to Keck Hospital of USC or USC Verdugo Hills Hospital for primary total knee arthroplasty or total hip arthroplasty.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Related 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.

  PMID: 16386799 BACKGROUND

• 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.

  PMID: 6744706 BACKGROUND

• 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.

  PMID: 29204500 BACKGROUND

MeSH Terms

Interventions

Povidone-Iodine; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which treatment arm they have been randomized to
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Orthopaedic Surgery

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: January 16, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)