StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Stopped early · Phase 2

Conditions studied: Trauma-related Wound, Burns, Skin Wound

In brief

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.

Key facts

Study ID

NCT03005054

Run by

Stratatech, a Mallinckrodt Company

People needed

3

Starts

2017-04-24

Expected to finish

2019-03-26

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18-65 years, inclusive
• Written informed consent
• Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
• Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
• Total skin defect may consist of more than one wound area
• Full-thickness complex skin defects requiring excision and autografting
• Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
• For thermal burns only, first excision and grafting of treatment sites

You may not qualify if…

• Pregnant women and prisoners
• Subjects receiving systemic immunosuppressive therapy
• Subjects with a known history of malignancy
• Preadmission insulin-dependent diabetic subjects
• Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
• Expected survival of less than three months
• Participation in the treatment group of an interventional study within the 90 days prior to enrollment
• Chronic wounds
• The face, head, neck, hands, feet, buttocks, perineum, and area over joints
• Treatment sites with exposed tendon or bony prominences
• Chemical and electrical burns
• Treatment sites adjacent to unexcised eschar
• Clinical suspicion of infection at the anticipated treatment sites

Where it is running

• Arizona Burn Center — Phoenix, Arizona, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• U.S. Army Institute of Surgical Research Adult Burn Center — Fort Sam Houston, Texas, United States
• University of Wisconsin Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.