Skin WoundPhase 3StrataSTEPSNCT05517902
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
A Phase 3 study testing StrataGraft in people with Skin Wound and Burns, run by Stratatech, a Mallinckrodt Company at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Skin Wound, Burns, Trauma-related Wound
- What is being tested?
- StrataGraft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2023to 9 May 2024
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
- Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
- Thermal burns of no more than a total of 30% TBSA
- Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
- Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
- Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Who cannot join
- Is pregnant or breastfeeding
- Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
- A known history of malignancy
- Pre-admission insulin-dependent diabetes
- Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
- A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
- Is participating in another interventional trial, or did within 90 days before enrollment
- A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns
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:
Read more
- Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves
- Treatment problems can require more grafting
- Additional surgery increases the risk of medical problems caused by the treatment
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.
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Being tested
- StrataGraft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataGraftBiological
StrataGraft® Construct
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: StrataGraft |
| 12 to ≤ 17 years Age Group Cohort | Experimental | Single application of StrataGraft to 0.5% to 10% TBSA on Day 1. Receives: Biological: StrataGraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Month 12
Secondary outcomes (3)
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.
Measured: At Week 12
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.
Measured: Up to Week 12
Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start28 Apr 2023
- Primary completion9 May 2024
- Study completion9 May 2024
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.
- Other trials for Skin WoundStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Stratatech, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517902
- Sponsor's protocol ID
- MNK15011001
- Acronym
- StrataSTEPS
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2022
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns
- ClinicalTrials.gov ID
- NCT05517902
- Acronym / sponsor ID
- StrataSTEPS / MNK15011001
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves
- Treatment problems can require more grafting
- Additional surgery increases the risk of medical problems caused by the treatment
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 to < 12 years Age Group Cohort | Experimental | Biological: StrataGraftSingle application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1. |
| 12 to ≤ 17 years Age Group Cohort | Experimental | Biological: StrataGraftSingle application of StrataGraft to 0.5% to 10% TBSA on Day 1. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
- Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
- Thermal burns of no more than a total of 30% TBSA
- Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
- Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
Key exclusion criteria (8 listed)
- Is pregnant or breastfeeding
- Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
- A known history of malignancy
- Pre-admission insulin-dependent diabetes
- Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
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 |
|---|---|---|
| StrataGraftStrataGraft® Construct | Biological | 12 to ≤ 17 years Age Group Cohort, 2 to < 12 years Age Group Cohort |
Primary outcome
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
Time frame: Up to Week 12
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Month 12
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.
3 secondary outcomes
Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement
Time frame: At Week 12
Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement
Time frame: Up to Week 12
Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12
Time frame: Up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinical Team Leader study director
Stratatech, a Mallinckrodt Company
1 site 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 in people with Skin Wound and Burns, run by Stratatech, a Mallinckrodt Company at 1 site 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 6 inclusion and 8 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 18 Mar 2025). 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?
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application (time frame: Up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.