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StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (StrataSTEPS)

Primary Purpose

Skin Wound, Burns, Trauma-related Wound

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

StrataGraft

About this trial

This is an interventional treatment trial for Skin Wound

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
Thermal burns of no more than a total of 30% TBSA
Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting

Exclusion Criteria:

Is pregnant or breastfeeding
Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
A known history of malignancy
Pre-admission insulin-dependent diabetes
Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
Is participating in another interventional trial, or did within 90 days before enrollment
A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia

Sites / Locations

Atrium Health Wake Forest BaptistRecruiting
Children's Hospital Medical Center of AkronRecruiting
Medical Univeristy of South CarolinaRecruiting
University of Wisconsin-MadisonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

2 to < 12 years Age Group Cohort

12 to ≤ 17 years Age Group Cohort

Arm Description

Participants of age 2 to < 12 years will receive a single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.

Participants of age 12 to ≤ 17 years will receive a single application of StrataGraft to 0.5% to 10% TBSA on Day 1.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Confirmed Complete Closure of StrataGraft Treatment Sites without Autograft within 12 Weeks of StrataGraft Application

Confirmed complete wound closure is defined as complete skin re-epithelialization of the wound without drainage observed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An Adverse Event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs are defined as those that are not present at start of study treatment or that represent the exacerbation of a pre-existing condition during the treatment-emergent period. The treatment-emergent period is defined as the time from first administration of StrataGraft to the end of the study for each participant.

Secondary Outcome Measures

Mean Percent Area of StrataGraft Treatment Site Closed at Week 12 Without Autograft Placement

The mean percent area of StrataGraft treatment site closed at Week 12 without autograft placement will be calculated using the percent of the total treatment site re-epithelialized without autografting at Week 12.

Mean Percent Area of StrataGraft Treatment Site Autografted by Week 12

The percent of the total treatment site area autografted will be calculated by using the percent of the total treatment site as the denominator and the area grafted as the numerator to calculate the percentage of the treatment site grafted.

Full Information

NCT ID

NCT05517902

First Posted

August 24, 2022

Last Updated

October 19, 2023

Sponsor

Stratatech, a Mallinckrodt Company

Collaborators

Biomedical Advanced Research and Development Authority

1. Study Identification

Unique Protocol Identification Number

NCT05517902

Brief Title

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

Acronym

StrataSTEPS

Official Title

A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2023 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stratatech, a Mallinckrodt Company

Collaborators

Biomedical Advanced Research and Development Authority

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

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns. It works to close the wound, but can cause other problems: Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves Treatment problems can require more grafting Additional surgery increases the risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study is to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns). Participants will be enrolled into one of two age-based cohorts: 2 to < 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso. The study will last for approximately 2.5 years.

6. Conditions and Keywords

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

Skin Wound, Burns, Trauma-related Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2 to < 12 years Age Group Cohort

Arm Type

Experimental

Arm Description

Participants of age 2 to < 12 years will receive a single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.

Arm Title

12 to ≤ 17 years Age Group Cohort

Arm Type

Experimental

Arm Description

Participants of age 12 to ≤ 17 years will receive a single application of StrataGraft to 0.5% to 10% TBSA on Day 1.

Intervention Type

Biological

Intervention Name(s)

StrataGraft

Intervention Description

StrataGraft® Construct

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Confirmed Complete Closure of StrataGraft Treatment Sites without Autograft within 12 Weeks of StrataGraft Application

Description

Confirmed complete wound closure is defined as complete skin re-epithelialization of the wound without drainage observed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20.

Time Frame

Up to 12 weeks

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Mean Percent Area of StrataGraft Treatment Site Closed at Week 12 Without Autograft Placement

Description

Time Frame

Week 12

Title

Mean Percent Area of StrataGraft Treatment Site Autografted by Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary Thermal burns of no more than a total of 30% TBSA Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting Exclusion Criteria: Is pregnant or breastfeeding Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted) A known history of malignancy Pre-admission insulin-dependent diabetes Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months Is participating in another interventional trial, or did within 90 days before enrollment A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia

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

Atrium Health Wake Forest Baptist

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Principal Investigator

Phone

336-716-1387

asaraswa@wakehealth.edu

Facility Name

Children's Hospital Medical Center of Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Coordinator

Phone

330-543-1000

jkatz@akronchildrens.org

Facility Name

Medical Univeristy of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Coordinator

Phone

843-792-0325

tresslar@musc.edu

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Coordinator

Phone

608-576-0788

research@surgery.wisc.edu

12. IPD Sharing Statement

Learn more about this trial

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

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