StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
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ClinicalTrials.gov Identifier: NCT01437852 |
Recruitment Status :
Completed
First Posted : September 21, 2011
Results First Posted : December 13, 2018
Last Update Posted : October 16, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | September 19, 2011 | |||
First Posted Date ICMJE | September 21, 2011 | |||
Results First Submitted Date ICMJE | October 3, 2017 | |||
Results First Posted Date ICMJE | December 13, 2018 | |||
Last Update Posted Date | October 16, 2019 | |||
Study Start Date ICMJE | September 2011 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns | |||
Official Title ICMJE | An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: StrataGraft Skin Tissue | |||
Study Arms ICMJE | Experimental: StrataGraft skin tissue
All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting Intervention: Biological: StrataGraft Skin Tissue
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | October 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01437852 | |||
Other Study ID Numbers ICMJE | STRATA2011 WFUHS 40269 ( Other Grant/Funding Number: AFIRM ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Mallinckrodt ( Stratatech, a Mallinckrodt Company ) | |||
Study Sponsor ICMJE | Stratatech, a Mallinckrodt Company | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mallinckrodt | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |