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Business Reason
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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 full-thickness (FT) burns.
It works to close the wound, but can cause other problems:
Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin.
All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 Group1: AG Tx Sites | Experimental | Participants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
|
| Cohort1 Group1: SOMA Tx Sites | Experimental | Participants received StrataGraft overlay of meshed autograft (SOMA Tx) at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm^2) in area on Day 1. |
|
| Cohort1 Group 2: AG Tx Sites | Experimental | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
|
| Cohort1 Group2: SOMA Tx Sites | Experimental | Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG Tx | Procedure | Control treatment that is meshed autograft alone applied to a burn area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported. | At Month 2 |
| Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure. | At Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
Is a prisoner, pregnant, or had previous autografting to treatment sites
Is expected to survive less than 3 months
Is participating in another interventional trial, or did within 30 days before enrollment
Has anticipated treatment sites that are outside protocol-specified parameters
Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology
Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Stratatech, a Mallinckrodt Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Tampa General Hospital / University of South Florida |
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The study was planned to be conducted in 2 cohorts. Only Cohort 1 data is reported, as the study was terminated before any participant was enrolled in Cohort 2. Total 13 participants were randomized in Cohort 1, each participant served as their own control. All participants had 2 treatment sites that were randomized to receive autograft treatment (AG Tx) at 1 treatment site, and StrataGraft overlay of meshed autograft (SOMA Tx) on the 2nd treatment site.
Participants took part in the study at 5 investigative sites in the United States from 10 October 2021 to 07 June 2024.
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort1 Group1: AG Tx | Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
| FG001 | Cohort1 Group1: SOMA Tx | Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm^2) in area on Day 1. |
| FG002 | Cohort1 Group2: AG Tx | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
| FG003 | Cohort1 Group2: SOMA Tx | Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Group 1 | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm^2 in area on Day 1. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported. | FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx. | Posted | Number | treatment sites | At Month 2 | sites | sites |
|
Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 Group 1: All Participants | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm^2 in area on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Homicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-844-2830 | medinfo@mnk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2023 | Mar 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2024 | Mar 6, 2025 | SAP_001.pdf |
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| SOMA Tx | Biological | Meshed autograft applied to the burn area and covered with StrataGraft. |
|
|
| Tampa |
| Florida |
| 33606 |
| United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Physician Decision |
|
| Cohort 1 Group 2 |
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm^2 in area on Day 1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Cohort1 Group1: SOMA Tx | Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. |
| OG002 | Cohort1 Group2: AG Tx | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. |
| OG003 | Cohort1 Group2: SOMA Tx | Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. |
|
|
|
| Primary | Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure. | FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx. Here, the overall number analyzed of participants are the number of participants with data available for analysis. | Posted | Count of Participants | Participants | At Month 12 |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| 7 |
| 7 |
| EG001 | Cohort 1 Group 1: AG Tx Sites | Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG002 | Cohort 1 Group 1: SOMA Tx Sites | Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG003 | Cohort 1 Group 2: All Participants | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm^2 in area on Day 1. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG004 | Cohort 1 Group 2: AG Tx Sites | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Cohort 1 Group 2: SOMA Tx Sites | Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm^2 in area on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Skin graft failure | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertrophic scar | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Staphylococcal skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Blood pressure diastolic abnormal | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
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