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

Status:	Recruiting
Conditions:	Other Indications, Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 65
Updated:	2/22/2019
Start Date:	April 24, 2017
End Date:	February 2020
Contact:	MNK Study Director
Email:	ClinicalTrials@mnk.com
Phone:	800-556-3314

Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

The proposed study is designed as a phase II open-label, controlled, randomized, multicenter,
dose-escalation study of the safety, tolerability, and efficacy of a single or multiple
applications of StrataGraft skin tissue as an alternative to autografting in promoting the
healing of excised full-thickness complex skin defects resulting from acute traumatic skin
loss. The proposed study population will include patients with up to 49% Total Body Surface
Area (TBSA) complex skin defects including a full-thickness component. The study has been
designed to focus on the evaluation of safety and tolerability of prolonged exposure to
increasing amounts of a single or multiple applications of StrataGraft skin tissue, while
also assessing the potential for StrataGraft tissue to promote healing of the full-thickness
component of these complex skin defects as an alternative to donor site harvesting and
autografting. Targeted enrollment for this study is up to 20 subjects with complex skin
defects due to acute traumatic skin loss which require surgical excision and autografting.
Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving
StrataGraft skin tissue.

Inclusion Criteria:

1. Men and women aged 18-65 years, inclusive

2. Written informed consent

3. Sufficient healthy skin identified and reserved as a donor site in the event that the
StrataGraft treatment site requires autografting

4. Complex skin defects of up to 49% TBSA requiring excision and autografting

- Total skin defect may consist of more than one wound area

5. Full-thickness complex skin defects requiring excision and autografting

6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400
cm2 in cohort 2

7. For thermal burns only, first excision and grafting of treatment sites

Exclusion Criteria:

1. Pregnant women and prisoners

2. Subjects receiving systemic immunosuppressive therapy

3. Subjects with a known history of malignancy

4. Preadmission insulin-dependent diabetic subjects

5. Subjects with concurrent conditions that in the opinion of the investigator may
compromise subject safety or study objectives

6. Expected survival of less than three months

7. Participation in the treatment group of an interventional study within the 90 days
prior to enrollment

8. Chronic wounds

9. The face, head, neck, hands, feet, buttocks, perineum, and area over joints

10. Treatment sites with exposed tendon or bony prominences

11. Chemical and electrical burns

12. Treatment sites adjacent to unexcised eschar

13. Clinical suspicion of infection at the anticipated treatment sites

We found this trial at

sites

U.S. Army Institute of Surgical Research Adult Burn Center

3698 Chambers Road
Fort Sam Houston, Texas 78234

Principal Investigator: MAJ Julie A Rizzo, MD

Phone: 210-916-6152

from

Fort Sam Houston, TX