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

• ClinicalTrials.gov Identifier: NCT03005106
• Recruitment Status: Completed
• First Posted: December 29, 2016
• Results First Posted: July 12, 2021
• Last Update Posted: July 14, 2021
• Sponsor: Stratatech, a Mallinckrodt Company
• Information provided by (Responsible Party): Mallinckrodt ( Stratatech, a Mallinckrodt Company )

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.

Condition or disease	Intervention/treatment	Phase
Burn, Thermal	Biological: StrataGraft Skin Tissue; Procedure: Autograft	Phase 3

Expanded Access : Stratatech, a Mallinckrodt Company has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: See detailed description
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 30, 2017
• Actual Primary Completion Date: July 31, 2019
• Actual Study Completion Date: March 27, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: StrataGraft Skin Tissue

Biological: StrataGraft Skin Tissue; 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®).; Procedure: Autograft; 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.

Outcome Measures

Primary Outcome Measures :

1. Percent Area of Treatment Sites Requiring Autografting by Month 3 [ Time Frame: 3 Months ]
   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).
2. Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) [ Time Frame: 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 :

1. Pain at the Designated Donor Sites by Day 14 [ Time Frame: Day 3, Day 7 and Day 14, average of the 3 days reported ]
   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.
2. Total Scar Assessment (POSAS) Score by Observer at Month 3 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of South Alabama Medical Center

Mobile, Alabama, United States, 36617

United States, Arizona

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, United States, 85008

United States, California

Universtiy of California - Irvine Health Regional Burn Center

Orange, California, United States, 92868

UC Davis

Sacramento, California, United States, 95817

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Florida

University of Florida Health Shands Burn Center

Gainesville, Florida, United States, 32610

Tampa General Hospital - Regional Burn Center

Tampa, Florida, United States, 33606

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Louisiana

Baton Rouge Medical Center

Baton Rouge, Louisiana, United States, 70809

University Medical Center

New Orleans, Louisiana, United States, 70112

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65212

United States, North Carolina

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15219

United States, Tennessee

Regional Medical Center Firefighters Burn Center

Memphis, Tennessee, United States, 38103

United States, Texas

U.S. Army Institute of Surgical Research Adult Burn Center

Fort Sam Houston, Texas, United States, 78234-6315

United States, Wisconsin

University of Wisconsin Hospital

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Stratatech, a Mallinckrodt Company

Investigators

• Study Director: Clinical Team Leader; Stratatech, a Mallinckrodt Company

  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):

Study Protocol and Statistical Analysis Plan  [PDF] May 30, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stratatech, a Mallinckrodt Company
• ClinicalTrials.gov Identifier: NCT03005106
• Other Study ID Numbers: STRATA2016
• First Posted: December 29, 2016
• Results First Posted: July 12, 2021
• Last Update Posted: July 14, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mallinckrodt ( Stratatech, a Mallinckrodt Company ):

Trauma-related wound; Deep partial thickness; Skin wound

Additional relevant MeSH terms:

Burns; Wounds and Injuries