Clinical trial NCT01437852: StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Wound
Burns
Trauma-related Wound
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Wound Closure of the Treatment Sites at Three Months
timeFrame: 3 months
measure: Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health Systems, Arizona Burn Center
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Hospital Burn Center
state: Colorado
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Dallas
country: United States
facility: UT-Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: U.S. Army Institute of Surgical Research
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company
name: Study Director
role: STUDY_DIRECTOR
References: