A Phase 3 interventional study of StrataGraft skin tissue in Deep Partial-thickness Burn, sponsored by Stratatech, a Mallinckrodt Company. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by Stratatech, a Mallinckrodt Company · Phase 3, Interventional, and Treatment
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.
Stratatech, a Mallinckrodt Company is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be considered for inclusion, a participant must:
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:
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.
Biological: StrataGraft 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.
Also known as: Experimental skin tissue
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).
Participants took part in the study across 10 study sites in the United States (US) from 21 February 2020 to 26 January 2022.
| Milestone | StrataGraft |
|---|---|
| Started | 52 |
| Completed | 38 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Death | 4 |
| Withdrew: Reason not specified | 1 |
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).
| Participants | StrataGraft |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 46 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| StrataGraft | 4/52 (7.7%) | 10/52 (19.2%) | 35/52 (67.3%) |
| Event | StrataGraft |
|---|---|
| Septic shockInfections and infestations | 2/52 |
| ArrhythmiaCardiac disorders | 1/52 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/52 |
| Cholecystitis acuteHepatobiliary disorders | 1/52 |
| Intervertebral discitisInfections and infestations | 1/52 |
| Pneumonia bacterialInfections and infestations | 1/52 |
| Pneumonia staphylococcalInfections and infestations | 1/52 |
| Wound infectionInfections and infestations | 1/52 |
| Intentional self-injuryInjury, poisoning and procedural complications | 1/52 |
| Tendon injuryInjury, poisoning and procedural complications | 1/52 |
| Event | StrataGraft |
|---|---|
| PruritusSkin and subcutaneous tissue disorders | 22/52 |
| PainGeneral disorders | 6/52 |
| ConstipationGastrointestinal disorders | 5/52 |
| NeuralgiaNervous system disorders | 5/52 |
| BlisterSkin and subcutaneous tissue disorders | 5/52 |
| Blood Loss anaemiaBlood and lymphatic system disorders | 3/52 |
| DeliriumPsychiatric disorders | 3/52 |
| CellulitisSkin and subcutaneous tissue disorders | 3/52 |
The modified intention-to-treat (mITT) population included all participants who were enrolled and received StrataGraft.
| Age, Continuous(years) | StrataGraft |
|---|---|
| Mean | 51.2 ± 17.00 |
| Sex: Female, Male(Participants) | StrataGraft |
|---|---|
| Female | 16 |
| Male | 36 |
| Ethnicity (NIH/OMB)(Participants) | StrataGraft |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 50 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | StrataGraft |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 42 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | StrataGraft |
|---|---|
| United States | 52 |
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Stratatech, a Mallinckrodt Company