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

NCT ID: NCT01437852

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Skin Wound; Burns; Trauma-related Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StrataGraft skin tissue

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

Group Type: EXPERIMENTAL

StrataGraft Skin Tissue

Intervention Type: BIOLOGICAL

Interventions

StrataGraft Skin Tissue

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stratatech, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company

Locations

Maricopa Integrated Health Systems, Arizona Burn Center

Phoenix, Arizona, United States

University of Colorado Hospital Burn Center

Aurora, Colorado, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

UT-Southwestern Medical Center

Dallas, Texas, United States

U.S. Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

University of Wisconsin Hospital

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

WFUHS 40269

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STRATA2011

Identifier Type: -

Identifier Source: org_study_id