StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Status:	Recruiting
Conditions:	Other Indications, Hospital, Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/10/2019
Start Date:	May 30, 2017
End Date:	March 2020
Contact:	MNK Study Director
Email:	ClinicalTrials@mnk.com
Phone:	800-556-3314

A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated

The proposed registration study is designed as a phase III open-label, controlled,
randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue
in promoting autologous skin tissue regeneration of complex skin defects due to thermal
burns. The proposed study will include patients with 3-49% total body surface area (TBSA)
complex skin defects due to thermal burns with intact dermal elements for which excision and
autografting are clinically indicated. The study has been designed to focus on the evaluation
of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for
StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an
alternative to donor site harvesting and autografting. Targeted enrollment for this study is
approximately 70 subjects with complex skin defects caused by thermal burns that containing
intact dermal elements and for which surgical excision and autografts are clinically
indicated.

Inclusion Criteria

Subject-specific criteria:

1. Men and women aged ≥ 18 years

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. Clinical expectation that the study donor site will heal without grafting

5. Complex skin defects of 3-49% TBSA

- Total burn may consist of more than one area

Treatment site-specific criteria:

6. Thermal burn(s) with intact dermal elements for which excision and autografting are
clinically indicated

7. Total of both study treatment areas can be up to 2000 cm2

8. First excision and grafting of study treatment sites

9. Thermal burn(s) on the torso, arms, or legs

Exclusion Criteria

Subject-specific criteria:

1. Pregnant women

2. Prisoners

3. Subjects receiving systemic immunosuppressive therapy

4. Subjects with a known history of malignancy

5. Preadmission insulin-dependent diabetic subjects

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

7. Expected survival of less than three months

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

Treatment site-specific criteria:

9. Full-thickness burns

10. Chronic wounds

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

12. Treatment sites immediately adjacent to unexcised eschar

13. Clinical or laboratory determination of infection at the anticipated treatment sites

We found this trial at

sites

MedStar Washington Hospital Center

Washington, District of Columbia

Principal Investigator: Jeffrey Shupp, MD

from

Washington,