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StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Primary Purpose

Burn, Thermal

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
StrataGraft Skin Tissue
Autograft
Sponsored by
Stratatech, a Mallinckrodt Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn, Thermal focused on measuring Trauma-related wound, Deep partial thickness, Skin wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama Medical Center
  • Arizona Burn Center at Maricopa Medical Center
  • Universtiy of California - Irvine Health Regional Burn Center
  • UC Davis
  • MedStar Washington Hospital Center
  • University of Florida Health Shands Burn Center
  • Tampa General Hospital - Regional Burn Center
  • University of Iowa
  • Baton Rouge Medical Center
  • University Medical Center
  • University of Missouri
  • Wake Forest University Baptist Medical Center
  • University of Pittsburgh Medical Center
  • Regional Medical Center Firefighters Burn Center
  • U.S. Army Institute of Surgical Research Adult Burn Center
  • University of Wisconsin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StrataGraft Skin Tissue

Arm Description

Outcomes

Primary Outcome Measures

Percent Area of Treatment Sites Requiring Autografting by Month 3
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.

Secondary Outcome Measures

Pain at the Designated Donor Sites by Day 14
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Total Scar Assessment (POSAS) Score by Observer at Month 3
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.

Full Information

First Posted
December 21, 2016
Last Updated
July 12, 2021
Sponsor
Stratatech, a Mallinckrodt Company
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1. Study Identification

Unique Protocol Identification Number
NCT03005106
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratatech, a Mallinckrodt Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn, Thermal
Keywords
Trauma-related wound, Deep partial thickness, Skin wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
See detailed description
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
StrataGraft Skin Tissue
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
StrataGraft Skin Tissue
Intervention Description
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
Intervention Type
Procedure
Intervention Name(s)
Autograft
Intervention Description
The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
Primary Outcome Measure Information:
Title
Percent Area of Treatment Sites Requiring Autografting by Month 3
Description
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Time Frame
3 Months
Title
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Description
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Pain at the Designated Donor Sites by Day 14
Description
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Time Frame
Day 3, Day 7 and Day 14, average of the 3 days reported
Title
Total Scar Assessment (POSAS) Score by Observer at Month 3
Description
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
Time Frame
at Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject-specific criteria: Men and women aged ≥ 18 years Written informed consent Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting Clinical expectation that the study donor site will heal without grafting Complex skin defects of 3-49% TBSA Total burn may consist of more than one area Treatment site-specific criteria: Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated Total of both study treatment areas can be up to 2000 cm2 First excision and grafting of study treatment sites Thermal burn(s) on the torso, arms, or legs Exclusion Criteria Subject-specific criteria: Pregnant women Prisoners Subjects receiving systemic immunosuppressive therapy Subjects with a known history of malignancy Preadmission insulin-dependent diabetic subjects Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives Expected survival of less than three months Participation in the treatment group of an interventional study within 90 days prior to enrollment Treatment site-specific criteria: Full-thickness burns Chronic wounds The face, head, neck, hands, feet, buttocks, and area over joints Treatment sites immediately adjacent to unexcised eschar Clinical or laboratory determination of infection at the anticipated treatment sites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Stratatech, a Mallinckrodt Company
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Arizona Burn Center at Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Universtiy of California - Irvine Health Regional Burn Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Health Shands Burn Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Tampa General Hospital - Regional Burn Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Baton Rouge Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Regional Medical Center Firefighters Burn Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
U.S. Army Institute of Surgical Research Adult Burn Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6315
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
Citations:
PubMed Identifier
34099322
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.
Results Reference
derived

Learn more about this trial

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

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