StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

Status:	Completed
Conditions:	Other Indications, Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 65
Updated:	12/15/2018
Start Date:	September 2011
End Date:	October 2014

An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study
evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the
healing of the deep partial-thickness component of complex skin defects. The proposed study
population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin
defects including a deep partial-thickness component resulting from thermal injury. The study
has been designed to focus on the evaluation of safety and tolerability of prolonged exposure
to increasing amounts of a single application of StrataGraft skin tissue, while also
assessing the potential for StrataGraft tissue to promote healing of the deep
partial-thickness component of these complex skin defects as an alternative to donor site
harvesting and autografting. Targeted enrollment for this study is up to 30 patients with
complex skin defects due to thermal burns which require surgical excision and autografting.
Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving
StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third
cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in
the operating room just prior to grafting.

Inclusion Criteria:

- Men and women aged 18-65 years, inclusive

- Written informed consent

- Sufficient healthy skin identified and designated as a donor site in the event that
the StrataGraft treatment site requires autografting

- Complex skin defects of 3-49% TBSA requiring excision and autografting

- Total burn may consist of more than one wound area

- Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring
excision and autografting

- First excision and grafting of treatment sites

Exclusion Criteria:

- Pregnant women and prisoners

- Patients receiving systemic immunosuppressive therapy

- Patients with a known history of malignancy

- Preadmission insulin-dependent diabetic patients

- Patients with concurrent conditions that in the opinion of the investigator may
compromise patient safety or study objectives

- Expected survival of less than three months

- Participation in the treatment group of an interventional study within preceding 90
days prior to enrollment

- Full-thickness burns will be excluded as treatment sites

- Chronic wounds will be excluded as treatment sites

- The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as
treatment sites

- Treatment sites adjacent to unexcised eschar

- Clinical suspicion of burn wound infection at the anticipated treatment sites

We found this trial at

sites

Maricopa Integrated Health Systems, Arizona Burn Center

Phoenix, Arizona 85008

from

Phoenix, AZ