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Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

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University of Southern California

Status

Terminated

Conditions

Periprosthetic Joint Infection

Treatments

Other: Sterile Water
Other: 3.5% Betadine
Other: 0.05% Chlorhexidine Gluconate

Study type

Interventional

Funder types

Other

Identifiers

NCT04274517
HS-19-01005

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Sterile Water
Experimental group
Treatment:
Other: Sterile Water
3.5% betadine
Experimental group
Treatment:
Other: 3.5% Betadine
0.05% chlorhexidine gluconate
Experimental group
Treatment:
Other: 0.05% Chlorhexidine Gluconate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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