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StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Primary Purpose

Trauma-related Wound, Burns, Skin Wound

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

StrataGraft Skin Tissue

Autograft

About this trial

This is an interventional treatment trial for Trauma-related Wound focused on measuring Full-thickness, Acute trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged 18-65 years, inclusive
Written informed consent
Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
- Total skin defect may consist of more than one wound area
Full-thickness complex skin defects requiring excision and autografting
Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
For thermal burns only, first excision and grafting of treatment sites

Exclusion Criteria:

Pregnant women and 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 the 90 days prior to enrollment
Chronic wounds
The face, head, neck, hands, feet, buttocks, perineum, and area over joints
Treatment sites with exposed tendon or bony prominences
Chemical and electrical burns
Treatment sites adjacent to unexcised eschar
Clinical suspicion of infection at the anticipated treatment sites

Sites / Locations

Arizona Burn Center
Wake Forest University Baptist Medical 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 the StrataGraft Treatment Site Requiring Autografting by Three Months

The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months

Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage

Secondary Outcome Measures

Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months

Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months

Percent Wound Closure at 3, 6, and 12 Months

Cosmesis of Treatment Sites at 3, 6, and 12 Months

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Cosmesis of Donor Sites at 3, 6, and 12 Months

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28

Full Information

NCT ID

NCT03005054

First Posted

December 21, 2016

Last Updated

July 13, 2021

Sponsor

Stratatech, a Mallinckrodt Company

1. Study Identification

Unique Protocol Identification Number

NCT03005054

Brief Title

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Official Title

Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Protracted enrollment and limited wound closure in the first three subjects

Study Start Date

April 24, 2017 (Actual)

Primary Completion Date

March 26, 2019 (Actual)

Study Completion Date

March 26, 2019 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Detailed Description

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma-related Wound, Burns, Skin Wound

Keywords

Full-thickness, Acute trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

See detailed description

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (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 complex skin defects. 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 wound.

Primary Outcome Measure Information:

Title

Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months

Description

The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

Time Frame

3 months

Title

Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months

Description

Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months

Time Frame

within 3 months

Title

Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months

Time Frame

within 3, 6 and 12 months

Title

Percent Wound Closure at 3, 6, and 12 Months

Time Frame

within 3, 6, and 12 Months

Title

Cosmesis of Treatment Sites at 3, 6, and 12 Months

Description

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Time Frame

within 3, 6, and 12 Months

Title

Cosmesis of Donor Sites at 3, 6, and 12 Months

Description

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Time Frame

within 3, 6, and 12 Months

Title

Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28

Time Frame

at days 3, 7, 14, 21, and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 18-65 years, inclusive Written informed consent Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting Total skin defect may consist of more than one wound area Full-thickness complex skin defects requiring excision and autografting Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2 For thermal burns only, first excision and grafting of treatment sites Exclusion Criteria: Pregnant women and 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 the 90 days prior to enrollment Chronic wounds The face, head, neck, hands, feet, buttocks, perineum, and area over joints Treatment sites with exposed tendon or bony prominences Chemical and electrical burns Treatment sites adjacent to unexcised eschar Clinical suspicion of infection at the anticipated treatment sites

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Mallinckrodt

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Burn Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

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

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

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 (NCT03005054) 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.

Learn more about this trial

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

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