Clinical trial NCT03005106: StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Official title: A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burn, Thermal
Keywords: Trauma-related wound
Deep partial thickness
Skin wound
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: See detailed description
Primary purpose: TREATMENT

Brief summary: About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.

The burns will:

* be on 3-49% of the participant's total body surface area (TBSA)
* require surgery for skin replacement
* include intact dermal elements

The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.

The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.

All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.

This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.


Eligibility criteria: Inclusion Criteria

Subject-specific criteria:

1. Men and women aged ≥ 18 years
2. Written informed consent
3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
4. Clinical expectation that the study donor site will heal without grafting
5. Complex skin defects of 3-49% TBSA

   * Total burn may consist of more than one area

   Treatment site-specific criteria:
6. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
7. Total of both study treatment areas can be up to 2000 cm2
8. First excision and grafting of study treatment sites
9. Thermal burn(s) on the torso, arms, or legs

Exclusion Criteria

Subject-specific criteria:

1. Pregnant women
2. Prisoners
3. Subjects receiving systemic immunosuppressive therapy
4. Subjects with a known history of malignancy
5. Preadmission insulin-dependent diabetic subjects
6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
7. Expected survival of less than three months
8. Participation in the treatment group of an interventional study within 90 days prior to enrollment

   Treatment site-specific criteria:
9. Full-thickness burns
10. Chronic wounds
11. The face, head, neck, hands, feet, buttocks, and area over joints
12. Treatment sites immediately adjacent to unexcised eschar
13. Clinical or laboratory determination of infection at the anticipated treatment sites

Primary outcomes:
measure: Percent Area of Treatment Sites Requiring Autografting by Month 3
timeFrame: 3 Months
measure: Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
timeFrame: Month 3
Secondary outcomes:
measure: Pain at the Designated Donor Sites by Day 14
timeFrame: Day 3, Day 7 and Day 14, average of the 3 days reported
measure: Total Scar Assessment (POSAS) Score by Observer at Month 3
timeFrame: at Month 3
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Medical Center
state: Arizona
city: Orange
country: United States
facility: Universtiy of California - Irvine Health Regional Burn Center
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health Shands Burn Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital - Regional Burn Center
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baton Rouge
country: United States
facility: Baton Rouge Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Regional Medical Center Firefighters Burn Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: U.S. Army Institute of Surgical Research Adult Burn Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Stratatech, a Mallinckrodt Company
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
citation: Gibson ALF, Holmes JH 4th, Shupp JW, Smith D, Joe V, Carson J, Litt J, Kahn S, Short T, Cancio L, Rizzo J, Carter JE, Foster K, Lokuta MA, Comer AR, Smiell JM, Allen-Hoffmann BL. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft(R) construct in patients with deep partial-thickness thermal burns. Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.