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NCT00618839 · ClinicalTrials.gov registry record · Phase 1
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00618839 is a Phase 1 study that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 15 participants.
The verdict
NCT00618839, a Phase 1 study, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Interventions
- BIOLOGICAL StrataGraft Skin Tissue
- PROCEDURE Cadaver allograft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618839
The ClinicalTrials.gov registry entry for NCT00618839 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stratatech, a Mallinckrodt Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which StrataGraft Skin Tissue is the first listed.
NCT00618839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00618839 about?
NCT00618839 is a clinical study titled "StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects". This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin deb...
What is the current status of trial NCT00618839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2006-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00618839?
The interventions under investigation include: StrataGraft Skin Tissue (BIOLOGICAL), Cadaver allograft (PROCEDURE).
Who is sponsoring clinical trial NCT00618839?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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