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StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01437852
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : December 13, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Wound Burns Trauma-related Wound Biological: StrataGraft Skin Tissue Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
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

 Biological: StrataGraft Skin Tissue


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Wound Closure of the Treatment Sites at Three Months [ Time Frame: 3 months ]
    Determination of complete wound closure of both treatment sites was evaluated at 3 months.

  2. Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 [ Time Frame: 28 days ]
    The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18-65 years, inclusive
  • Written informed consent
  • Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting
  • Complex skin defects of 3-49% TBSA requiring excision and autografting
  • Total burn may consist of more than one wound area
  • Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting
  • First excision and grafting of treatment sites

Exclusion Criteria:

  • Pregnant women and prisoners
  • Patients receiving systemic immunosuppressive therapy
  • Patients with a known history of malignancy
  • Preadmission insulin-dependent diabetic patients
  • Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
  • Expected survival of less than three months
  • Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment
  • Full-thickness burns will be excluded as treatment sites
  • Chronic wounds will be excluded as treatment sites
  • The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites
  • Treatment sites adjacent to unexcised eschar
  • Clinical suspicion of burn wound infection at the anticipated treatment sites
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437852


Locations
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United States, Arizona
Maricopa Integrated Health Systems, Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, Colorado
University of Colorado Hospital Burn Center
Aurora, Colorado, United States, 80045
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Texas
UT-Southwestern Medical Center
Dallas, Texas, United States, 75390-9158
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-6315
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
Investigators
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Study Director: Study Director Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company
More Information
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Responsible Party: Stratatech, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT01437852    
Other Study ID Numbers: STRATA2011
WFUHS 40269 ( Other Grant/Funding Number: AFIRM )
First Posted: September 21, 2011    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: October 16, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Wounds and Injuries