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StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
NCT01437852 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 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 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01437852 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01437852?
The interventions under investigation include: StrataGraft Skin Tissue (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01437852?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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