StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects (NCT03005054) | Clinical Trial Compass
TerminatedPhase 2
StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
Stopped: Protracted enrollment and limited wound closure in the first three subjects
United States3 participantsStarted 2017-04-24
Plain-language summary
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Men and women aged 18-65 years, inclusive
âś“. Written informed consent
âś“. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
âś“. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
âś“. Full-thickness complex skin defects requiring excision and autografting
âś“. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
âś“. For thermal burns only, first excision and grafting of treatment sites