Burn, ThermalPhase 3NCT03005106
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
A Phase 3 study testing StrataGraft Skin Tissue and Autograft in people with Burn, Thermal, run by Stratatech, a Mallinckrodt Company at 16 sites in United States.
Trial summary
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat. The burns will: be on 3-49% of the participant's total body surface area (TBSA) require surgery for skin replacement include intact dermal elements The burns are called deep, partial-thickness thermal burns… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Thermal
- What is being tested?
- StrataGraft Skin Tissue and Autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 May 2017to 27 Mar 2020
- 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
- Subject-specific criteria:
- Men and women aged ≥ 18 years
- Written informed consent
- Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- Clinical expectation that the study donor site will heal without grafting
- Complex skin defects of 3-49% TBSA
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- Total burn may consist of more than one area
- Treatment site-specific criteria:
- Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
- Total of both study treatment areas can be up to 2000 cm2
- First excision and grafting of study treatment sites
- Thermal burn(s) on the torso, arms, or legs
Who cannot join
- Subject-specific criteria:
- Pregnant women
- Prisoners
- Subjects receiving systemic immunosuppressive therapy
- Subjects with a known history of malignancy
- Preadmission insulin-dependent diabetic subjects
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- Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
- Expected survival of less than three months
- Participation in the treatment group of an interventional study within 90 days prior to enrollment
- Treatment site-specific criteria:
- Full-thickness burns
- Chronic wounds
- The face, head, neck, hands, feet, buttocks, and area over joints
- Treatment sites immediately adjacent to unexcised eschar
- Clinical or laboratory determination of infection at the anticipated treatment sites
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Baton Rouge Medical Center
Baton Rouge, Louisiana, 70809
University of Missouri
Columbia, Missouri, 65212
U.S. Army Institute of Surgical Research Adult Burn Center
Fort Sam Houston, Texas, 78234-6315
University of Florida Health Shands Burn Center
Gainesville, Florida, 32610
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Regional Medical Center Firefighters Burn Center
Memphis, Tennessee, 38103
University of South Alabama Medical Center
Mobile, Alabama, 36617
University Medical Center
New Orleans, Louisiana, 70112
Universtiy of California - Irvine Health Regional Burn Center
Orange, California, 92868
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, 85008
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
UC Davis
Sacramento, California, 95817
Tampa General Hospital - Regional Burn Center
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
Read more
- be on 3-49% of the participant's total body surface area (TBSA)
- require surgery for skin replacement
- include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
- Conditions
- Burn, Thermal
- Being tested
- StrataGraft Skin Tissue, Autograft
- Keywords
- Trauma-related wound, Deep partial thickness, Skin wound
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataGraft Skin TissueBiological
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
AutograftProcedure or surgery
The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
| Study group | Role | What they receive |
|---|---|---|
| StrataGraft Skin Tissue | Experimental | Not described Receives: Biological: StrataGraft Skin Tissue; Procedure: Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Area of Treatment Sites Requiring Autografting by Month 3
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Measured: 3 Months
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
Measured: Month 3
Secondary outcomes (2)
Pain at the Designated Donor Sites by Day 14
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Measured: Day 3, Day 7 and Day 14, average of the 3 days reported
Total Scar Assessment (POSAS) Score by Observer at Month 3
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
Measured: at Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start30 May 2017
- Primary completion31 Jul 2019
- Study completion27 Mar 2020
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 Burn, ThermalStudies 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
- Model description
- See detailed description
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Stratatech, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005106
- Sponsor's protocol ID
- STRATA2016
- Status last verified
- Jul 2021
- First submitted
- 21 Dec 2016
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
- Expanded access
- Available
Publications
Gibson ALF, Holmes JH 4th, Shupp JW, Smith D, Joe V, Carson J, Litt J, Kahn S, Short T, Cancio L, Rizzo J, Carter JE, Foster K, Lokuta MA, Comer AR, Smiell JM, Allen-Hoffmann BL. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft(R) construct in patients with deep partial-thickness thermal burns. Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.
PubMed 34099322
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated
- ClinicalTrials.gov ID
- NCT03005106
- Acronym / sponsor ID
- STRATA2016
- Conditions
- Burn, Thermal
- Keywords
- Trauma-related wound, Deep partial thickness, Skin wound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 12 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
- be on 3-49% of the participant's total body surface area (TBSA)
- require surgery for skin replacement
- include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- See detailed description
| Arm | Type | Receives |
|---|---|---|
| StrataGraft Skin Tissue | Experimental | Biological: StrataGraft Skin Tissue, Procedure: Autograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women aged ≥ 18 years
- Written informed consent
- Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- Clinical expectation that the study donor site will heal without grafting
- Complex skin defects of 3-49% TBSA
Key exclusion criteria (15 listed)
- Pregnant women
- Prisoners
- Subjects receiving systemic immunosuppressive therapy
- Subjects with a known history of malignancy
- Preadmission insulin-dependent diabetic subjects
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 TissueStrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). | Biological | StrataGraft Skin Tissue |
| AutograftThe current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound. | Procedure or surgery | StrataGraft Skin Tissue |
Primary outcome
Percent Area of Treatment Sites Requiring Autografting by Month 3
Time frame: 3 Months
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Time frame: Month 3
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
2 secondary outcomes
Pain at the Designated Donor Sites by Day 14
Time frame: Day 3, Day 7 and Day 14, average of the 3 days reported
Total Scar Assessment (POSAS) Score by Observer at Month 3
Time frame: at Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34099322Gibson ALF, Holmes JH 4th, Shupp JW, Smith D, Joe V, Carson J, Litt J, Kahn S, Short T, Cancio L, Rizzo J, Carter JE, Foster K, Lokuta MA, Comer AR, Smiell JM, Allen-Hoffmann BL. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft(R) construct in patients with deep partial-thickness thermal burns. Burns. 2021 Aug;47(5):1024-1037. doi: 10.1016/j.burns.2021.04.021. Epub 2021 Apr 23.
- Individual participant dataSharing planned: No. Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
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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
16 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 and Autograft in people with Burn, Thermal, run by Stratatech, a Mallinckrodt Company at 16 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 12 inclusion and 15 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 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 12 Jul 2021). 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?
Percent Area of Treatment Sites Requiring Autografting by Month 3 (time frame: 3 Months). 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?
On the ClinicalTrials.gov record for NCT03005106, 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 14 Jul 2021.