Deep Partial-thickness Burn
Conditions
Keywords
Alternative to Autograft
Brief summary
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. * StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns. * There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available. 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.
Detailed description
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.
Interventions
BIOLOGICALStrataGraft skin tissue
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.
Sponsors
Stratatech, a Mallinckrodt Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. that are the right size for treatment areas, 2. with intact dermal elements for which excision and autografting are clinically indicated, and 3. have not been previously excised and grafted.
Exclusion criteria
A participant must be excluded from participation if he/she: * Is pregnant, a prisoner, or expected to live less than 3 months * Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives * Has participated in an investigational study within 90 days before enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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). | 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). |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study across 10 study sites in the United States (US) from 21 February 2020 to 26 January 2022.
Pre-assignment details
A total of 60 participants were screened of which, 52 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Reason Not Specified | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | StrataGraft |
|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 52 |
| other Total, other adverse events | 35 / 52 |
| serious Total, serious adverse events | 10 / 52 |
Outcome results
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).
Time frame: 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).
Population: mITT population included all participants who were enrolled and received StrataGraft.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| StrataGraft | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 46 Participants |