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NCT04274517 · ClinicalTrials.gov registry record · NA
Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty
A NA study, sponsored by University of Southern California.
- Terminated
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04274517: Clinical Trial NA study, sponsored by University of Southern California.
NCT04274517 is a NA study that was terminated before completion, run by University of Southern California. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04274517, a NA study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- OTHER 0.05% Chlorhexidine Gluconate
- OTHER Sterile Water
- OTHER 3.5% Betadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-16 |
| Est. Completion | 2022-06-01 |
| Phase | NA |
Why NCT04274517 stopped before completion
NCT04274517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which 0.05% Chlorhexidine Gluconate is the first listed.
NCT04274517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04274517 about?
NCT04274517 is a clinical study titled "Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty". 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 infe...
What is the current status of trial NCT04274517?
This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2021-01-16. Estimated completion is 2022-06-01.
What interventions are being tested in trial NCT04274517?
The interventions under investigation include: 0.05% Chlorhexidine Gluconate (OTHER), Sterile Water (OTHER), 3.5% Betadine (OTHER).
Who is sponsoring clinical trial NCT04274517?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04274517's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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