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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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 DPT burns.
It works to close the wound, but can cause other problems:
Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was 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 were 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 to < 12 years Age Group Cohort | Experimental | Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1. |
|
| 12 to ≤ 17 years Age Group Cohort | Experimental | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrataGraft | Biological | StrataGraft® Construct |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved 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 confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported. | Up to Week 12 |
| 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. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement | Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at 2 consecutive visits at least 2 weeks apart. | At Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Stratatech, a Mallinckrodt Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madison | Wisconsin | 53715 | United States |
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Participant took part in the study at a single clinical site in the United States from 28 April 2023 to 9 May 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 to < 12 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1. |
| FG001 | 12 to ≤ 17 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all participants who were enrolled and received StrataGraft.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 to < 12 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
| BG001 | 12 to ≤ 17 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants Who Achieved 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 confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported. | Safety population included all participants who were enrolled and received StrataGraft. | Posted | Number | percentage of participants | Up to Week 12 |
|
Up to 12 months
Safety population included all participants who were enrolled and received StrataGraft.
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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 | 2 to < 12 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
This study had low accrual and only 1 participant was enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 1-800-844-2830 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan | Sep 26, 2023 | Jan 9, 2025 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan_Memo | Jul 3, 2024 | Jan 9, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement | Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at two consecutive visits at least two weeks apart. | Up to Week 12 |
| Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12 | Up to Week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 12 to ≤ 17 Years Age Group Cohort |
Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
|
|
| Primary | 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. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment. | Safety population included all participants who were enrolled and received StrataGraft. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| Secondary | Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement | Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at 2 consecutive visits at least 2 weeks apart. | Safety population included all participants who were enrolled and received StrataGraft. | Posted | Number | percentage of treatment sites | At Week 12 |
|
|
|
| Secondary | Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement | Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at two consecutive visits at least two weeks apart. | Safety population included all participants who were enrolled and received StrataGraft. | Posted | Number | number of complete wound closure | Up to Week 12 |
|
|
|
| Secondary | Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12 | Safety population included all participants who were enrolled and received StrataGraft. None of the participant had StrataGraft treatment site that required autografting. | Posted | Up to Week 12 |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 12 to ≤ 17 Years Age Group Cohort | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. | 0 | 0 | 0 | 0 | 0 | 0 |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
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