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

Purpose

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 20 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.

Condition	Intervention	Phase
Skin Wound Burns Infection Related Wound Trauma-related Wound	Biological: StrataGraft Skin Tissue	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Burns Injuries Wounds

U.S. FDA Resources

Further study details as provided by Stratatech:

Primary Outcome Measures:

Wound closure of the treatment sites at three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Determination of complete wound closure of both treatment sites will be evaluated at three months.
Percent area of the StrataGraft treatment site requiring autografting by day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by day 28 will be determined.

Estimated Enrollment:	20
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: StrataGraft skin tissue	Biological: StrataGraft Skin Tissue StrataGraft® skin tissue is provided as a suturable circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal keratinocytes (NIKS®).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437852

Locations

United States, Arizona
Maricopa Integrated Health Systems, Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, Colorado
University of Colorado Hospital Burn Center
Aurora, Colorado, United States, 80045
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Texas
UT-Southwestern Medical Center
Dallas, Texas, United States, 75390-9158
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-6315
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Stratatech

More Information

No publications provided

Responsible Party:	Stratatech
ClinicalTrials.gov Identifier:	NCT01437852 History of Changes
Other Study ID Numbers:	STRATA2011, WFUHS 40269
Study First Received:	September 19, 2011
Last Updated:	August 31, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013