StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
Completed · Phase 1/Phase 2
Conditions studied: Third Degree Burn, Burns, Wound Infection, Degloving Injury
In brief
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 defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Key facts
- Study ID
- NCT00618839
- Run by
- Stratatech, a Mallinckrodt Company
- People needed
- 15
- Starts
- 2006-07-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2019-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arizona Burn & Trauma Center — Phoenix, Arizona, United States
- University of Wisconsin-Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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