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NCT00547638 · ClinicalTrials.gov registry record · Phase 2
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
A Phase 2 study, sponsored by Ethicon.
- Completed
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
NCT00547638: Completed Phase 2 study, sponsored by Ethicon.
NCT00547638 is a Phase 2 study that has completed, run by Ethicon. The registered enrollment target is 216 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00547638, a Phase 2 study, has completed, sponsored by Ethicon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
Study Summary
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.
Primary Outcome
Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.
Interventions
- DEVICE cyanoacrylate with pressure sensitive mesh
- DEVICE cyanoacrylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00547638 record still lists
NCT00547638 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 2 interventions - of which cyanoacrylate with pressure sensitive mesh is the first listed.
NCT00547638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00547638 about?
NCT00547638 is a clinical study titled "Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure". This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent ...
What is the current status of trial NCT00547638?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2007-08. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00547638?
The interventions under investigation include: cyanoacrylate with pressure sensitive mesh (DEVICE), cyanoacrylate (DEVICE).
Who is sponsoring clinical trial NCT00547638?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00547638's enrollment target sits among peer trials
216 286th of 2000 higher than 1,712 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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