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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: Completed Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
NCT00618839 is a Phase 1 study that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with 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 |
What the finished NCT00618839 record still lists
NCT00618839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which StrataGraft Skin Tissue is the first listed.
NCT00618839 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618839's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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