Deep Partial-thickness BurnPhase 3NCT04123548
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
A Phase 3 study testing StrataGraft skin tissue in people with Deep Partial-thickness Burn, run by Stratatech, a Mallinckrodt Company at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Partial-thickness Burn
- What is being tested?
- StrataGraft skin tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Feb 2020to 26 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- that are the right size for treatment areas,
- with intact dermal elements for which excision and autografting are clinically indicated, and
- have not been previously excised and grafted.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Baton Rouge General
Baton Rouge, Louisiana, 70809
University of Missouri
Columbia, Missouri, 33136
University of Florida (Health Shands Burn Center)
Gainesville, Florida, 32610
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin Hospital
Madison, Wisconsin, 53792
University Medical Center New Orleans
New Orleans, Louisiana, 70113
University of California Irvine
Orange, California, 92868-3298
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns
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.
Read more
- 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.
Read the 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.
- Conditions
- Deep Partial-thickness Burn
- Being tested
- StrataGraft skin tissue
- Keywords
- Alternative to Autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataGraft skin tissueBiological
Also called Experimental 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: StrataGraft skin tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start18 Feb 2020
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Partial-thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Stratatech, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123548
- Sponsor's protocol ID
- MNK01053115
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2019
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39043513
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Study of StrataGraft® Skin Tissue in Adult Subjects With Deep Partial-Thickness Thermal Burns
- ClinicalTrials.gov ID
- NCT04123548
- Acronym / sponsor ID
- MNK01053115
- Conditions
- Deep Partial-thickness Burn
- Keywords
- Alternative to Autograft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StrataGraft | Experimental | Biological: StrataGraft skin tissueOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrataGraft skin tissueAlso: Experimental skin tissueStrataGraft 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. | Biological | StrataGraft |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39043513Holmes 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.
- Individual participant dataSharing planned: No
Related trials for Deep Partial-thickness Burn
RecruitingPhase 3
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Burns
Active, not recruitingPhase 2
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
Burns
Enrolling by invitationPhase 4
Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns
Partial-thickness Burn Wounds
RecruitingPhase 2
Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Burn, Burn Wounds - Partial Thickness (2nd Degree)
RecruitingPhase 3
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Burns Degree Third, Burn (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Stratatech, a Mallinckrodt Company
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing StrataGraft skin tissue in people with Deep Partial-thickness Burn, run by Stratatech, a Mallinckrodt Company at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04123548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.