Status:
COMPLETED
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
Lead Sponsor:
Stratatech, a Mallinckrodt Company
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Third Degree Burn
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defe...
Detailed Description
Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debr...
Eligibility Criteria
Inclusion
- Patients aged greater than 18 yrs.
- Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
- Full-thickness skin defects
- Informed consent
Exclusion
- Prisoners
- Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
- Immunosuppressive therapy
- Infection with Human Immunodeficiency Virus
- Venous stasis ulcers of the lower leg
- Diabetic foot ulcers
- Donor site wounds
- Wounds of less than 5% body surface area
- Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)
- Prior entry into this study
- Expected survival of less than 3 months
- Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)
- Use of an investigational agent within 30 days
- Active malignancy
- Clinical evidence of malnutrition
- Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00618839
Start Date
July 1 2006
End Date
April 1 2008
Last Update
October 16 2019
Active Locations (2)
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1
Arizona Burn & Trauma Center
Phoenix, Arizona, United States, 85008
2
University of Wisconsin-Hospital and Clinics
Madison, Wisconsin, United States, 53792