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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stratatech
ClinicalTrials.gov Identifier:
NCT01437852
First received: September 19, 2011
Last updated: October 11, 2013
Last verified: October 2013
  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 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.


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:


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: 30
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014