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NCT01184196 · ClinicalTrials.gov registry record · Phase 4
ChloraPrep Versus Betadine for Elective Knee Replacement Surgery
A Phase 4 study, sponsored by Central DuPage Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT01184196: Clinical Trial Phase 4 study, sponsored by Central DuPage Hospital.
NCT01184196 is a Phase 4 study that was terminated before completion, run by Central DuPage Hospital. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01184196, a Phase 4 study, was terminated before completion, sponsored by Central DuPage Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements. Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.
Primary Outcome
Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.
Interventions
- DRUG Swab area with Betadine
- DRUG Swab area with ChloraPrep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
Why NCT01184196 stopped before completion
NCT01184196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Swab area with Betadine is the first listed.
NCT01184196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01184196 about?
NCT01184196 is a clinical study titled "ChloraPrep Versus Betadine for Elective Knee Replacement Surgery". This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements. Study hypothesis: When used as a surgical scrub preparation prior to p...
What is the current status of trial NCT01184196?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2009-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01184196?
The interventions under investigation include: Swab area with Betadine (DRUG), Swab area with ChloraPrep (DRUG).
Who is sponsoring clinical trial NCT01184196?
This trial is sponsored by Central DuPage Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01184196's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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