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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

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

Intervention / Treatment
-----------------
* Biological: StrataGraft Skin Tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataGraft skin tissue<br>All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting | Biological: StrataGraft Skin Tissue<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Closure of the Treatment Sites at Three Months | Determination of complete wound closure of both treatment sites was evaluated at 3 months. | 3 months | 
| Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 | The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined. | 28 days |