Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT04274517
Collaborator
(none)
270
1
3
34.5
7.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sterile Water
  • Other: 3.5% Betadine
  • Other: 0.05% Chlorhexidine Gluconate
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will not know which treatment arm they have been randomized to
Primary Purpose:
Prevention
Official Title:
The Effect of Dilute Chlorhexidine Versus Betadine on Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty: A Prospective Clinical Trial
Actual Study Start Date :
Jan 16, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Keck School of Medicine of USC Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nathanael Heckmann, Assistant Professor of Clinical Orthopaedic Surgery, University of Southern California
ClinicalTrials.gov Identifier:
NCT04274517
Other Study ID Numbers:
  • HS-19-01005
First Posted:
Feb 18, 2020
Last Update Posted:
Jan 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022