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NCT01437852 · ClinicalTrials.gov registry record · Phase 1
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
A Phase 1 study of Burns and Skin Wound, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT01437852 is a Phase 1 study of Burns and Skin Wound that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 30 participants, below the 82-participant average among 36 other Burns trials with a reported enrollment target (63% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT01437852, a Phase 1 study of Burns and Skin Wound, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Conditions Studied
Interventions
- BIOLOGICAL StrataGraft Skin Tissue
Study Locations (6)
Texas
- UT-Southwestern Medical Center - Dallas
- U.S. Army Institute of Surgical Research - Fort Sam Houston
Arizona
- Maricopa Integrated Health Systems, Arizona Burn Center - Phoenix
Colorado
- University of Colorado Hospital Burn Center - Aurora
North Carolina
- Wake Forest University Baptist Medical Center - Winston-Salem
Wisconsin
- University of Wisconsin Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01437852
The ClinicalTrials.gov registry entry for NCT01437852 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 36 other Burns trials with a reported enrollment target (63% lower). The listed sponsor is Stratatech, a Mallinckrodt Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Burns appearing as the primary indexed condition, and to 1 intervention - of which StrataGraft Skin Tissue is the first listed.
NCT01437852 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Texas, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT01437852 about?
NCT01437852 is a clinical study titled "StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns". The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will includ...
What is the current status of trial NCT01437852?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-09. Estimated completion is 2014-10.
What conditions does trial NCT01437852 study?
This clinical trial studies the following conditions: Burns, Skin Wound, Trauma-related Wound.
What interventions are being tested in trial NCT01437852?
The interventions under investigation include: StrataGraft Skin Tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT01437852?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01437852 being conducted?
This trial has 6 study locations across Arizona, Colorado, North Carolina, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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