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An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body.
StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft.
The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.
The primary purpose of this trial was to provide expanded access to StrataGraft for thermally induced DPT burns that contained intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StrataGraft | Experimental | On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 square centimeters (cm^2) in area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrataGraft skin tissue | Biological | StrataGraft skin tissue was delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 2000 cm^2 of treatment area using no more than 20 tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft). | AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months). |
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Inclusion Criteria:
To be considered for inclusion, a participant must:
Provide written informed consent
Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities:
Exclusion Criteria:
A participant must be excluded from participation if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Stratatech, a Mallinckrodt Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868-3298 | United States | ||
| MedStar Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39043513 | Derived | Holmes Iv JH, Gibson ALF, Short T, Joe VC, Litt J, Carson J, Carter JE, Wibbenmeyer L, Hahn H, Smiell JM, Rutan R, Wu R, Shupp JW. A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft(R) treatment in adults with deep partial-thickness thermal burns. Burns. 2024 Nov;50(8):2013-2022. doi: 10.1016/j.burns.2024.05.023. Epub 2024 Jun 6. |
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A total of 60 participants were screened of which, 52 participants were enrolled in the study.
Participants took part in the study across 10 study sites in the United States (US) from 21 February 2020 to 26 January 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | StrataGraft | On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 deep partial thickness (DPT) wound(s) totaling no more than approximately 2000 square centimeters (cm^2) in area. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 2, 2020 | Oct 18, 2023 |
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|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Florida (Health Shands Burn Center) | Gainesville | Florida | 32610 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Baton Rouge General | Baton Rouge | Louisiana | 70809 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70113 | United States |
| University of Missouri | Columbia | Missouri | 33136 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The modified intention-to-treat (mITT) population included all participants who were enrolled and received StrataGraft.
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| ID | Title | Description |
|---|---|---|
| BG000 | StrataGraft | On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm^2 in area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. A TEAE is defined as an adverse event that started on or after the start of treatment (i.e. placement of StrataGraft). | mITT population included all participants who were enrolled and received StrataGraft. | Posted | Count of Participants | Participants | AEs were collected on each individual participant for the duration of their study participation, i.e. from the time of signing the informed consent until study completion (up to approximately 7 months). |
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AEs were collected on each participant for the duration of the study participation i.e. from the time of signing the informed consent until study completion (up to approximately 7 months).
mITT population included all participants who were enrolled and received StrataGraft. TEAEs are defined as those adverse events with onset date and time after the first placement of study product or those events in which the onset date and time are before the first placement of study product but worsened after the first placement of study product.
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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 | StrataGraft | On Day 1, participants received a single application of up to 1:1 meshed StrataGraft skin tissue on up to 3 DPT wound(s) totaling no more than approximately 2000 cm^2 in area. | 4 | 52 | 10 | 52 | 35 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Pneumonia staphylococcal | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Intentional self-injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Tendon injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Myocardial infarction | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Loss anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-844-2830 | medinfo@mnk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2022 | Oct 18, 2023 | SAP_001.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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