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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Skin Wound; Trauma-related Wound
• Intervention / Treatment: Biological: StrataGraft Skin Tissue

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Biological: StrataGraft Skin Tissue

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

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Investigators: Study Director: Study Director, Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: STRATA2011; WFUHS 40269 (Other Grant/Funding Number: AFIRM)