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NCT00739583 · ClinicalTrials.gov registry record · Phase 4
Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00739583: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT00739583 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00739583, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell w
Primary Outcome
The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.
Interventions
- DRUG CHG 2% w/v and IPA 70% v/v
- DRUG Iodophor 0.7% and IPA 74% w/w
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
What the finished NCT00739583 record still lists
NCT00739583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which CHG 2% w/v and IPA 70% v/v is the first listed.
NCT00739583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00739583 about?
NCT00739583 is a clinical study titled "Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions". Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of...
What is the current status of trial NCT00739583?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2008-08. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00739583?
The interventions under investigation include: CHG 2% w/v and IPA 70% v/v (DRUG), Iodophor 0.7% and IPA 74% w/w (DRUG).
Who is sponsoring clinical trial NCT00739583?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00739583's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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