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NCT00731367 · ClinicalTrials.gov registry record · Phase 3
Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
A Phase 3 study, sponsored by ConvaTec.
- Completed
- Registry status
- Phase 3
- Development phase
- 73
- Enrollment target
NCT00731367 is a Phase 3 study that has completed, run by ConvaTec. The registered enrollment target is 73 participants.
The verdict
NCT00731367, a Phase 3 study, has completed, sponsored by ConvaTec.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 73 participants
- Enrollment target
Study Summary
This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state. The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.
Interventions
- DEVICE Aquacel Ag Gelled
- DEVICE Aquacel Ag Adherent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731367
The ClinicalTrials.gov registry entry for NCT00731367 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ConvaTec, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aquacel Ag Gelled is the first listed.
NCT00731367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00731367 about?
NCT00731367 is a clinical study titled "Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites". This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care w...
What is the current status of trial NCT00731367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2005-10. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00731367?
The interventions under investigation include: Aquacel Ag Gelled (DEVICE), Aquacel Ag Adherent (DEVICE).
Who is sponsoring clinical trial NCT00731367?
This trial is sponsored by ConvaTec, which has 17 total clinical trials registered on ClinicalTrials.gov.
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