Status:
COMPLETED
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
Lead Sponsor:
Stratatech, a Mallinckrodt Company
Conditions:
Skin Wound
Burns
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01437852
Start Date
September 1 2011
End Date
October 1 2014
Last Update
October 16 2019
Active Locations (6)
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1
Maricopa Integrated Health Systems, Arizona Burn Center
Phoenix, Arizona, United States, 85008
2
University of Colorado Hospital Burn Center
Aurora, Colorado, United States, 80045
3
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
4
UT-Southwestern Medical Center
Dallas, Texas, United States, 75390-9158