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

NCT03005106 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: STRATA2016
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 16

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.

Conditions

Burn, Thermal

Keywords

Trauma-related wound; Deep partial thickness; Skin wound

Outcome Measures

Primary Outcomes (2)

• 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).

  3 Months

• 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.

  Month 3

Secondary Outcomes (2)

• Pain at the Designated Donor Sites by Day 14

  Day 3, Day 7 and Day 14, average of the 3 days reported

• Total Scar Assessment (POSAS) Score by Observer at Month 3

  at Month 3

Study Arms (1)

StrataGraft Skin Tissue

EXPERIMENTAL

Biological: StrataGraft Skin Tissue; Procedure: Autograft

Interventions

StrataGraft Skin Tissue BIOLOGICAL

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®).

StrataGraft Skin Tissue

Autograft PROCEDURE

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.

StrataGraft Skin Tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead

Study Sites (16)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Arizona Burn Center at Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Universtiy of California - Irvine Health Regional Burn Center

Orange, California, 92868, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health Shands Burn Center

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital - Regional Burn Center

Tampa, Florida, 33606, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Baton Rouge Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Regional Medical Center Firefighters Burn Center

Memphis, Tennessee, 38103, United States

Location

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

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

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 34099322 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

MedInfo@mnk.com

800-844-2830

Study Officials

• Clinical Team Leader

  Stratatech, a Mallinckrodt Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: See detailed description

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: May 30, 2017
• Primary Completion: July 31, 2019
• Study Completion: March 27, 2020
• Last Updated: July 14, 2021
• Results First Posted: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)