Trauma-related WoundPhase 2NCT03005054
StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
A Phase 2 study testing StrataGraft Skin Tissue and Autograft in people with Trauma-related Wound and Burns, run by Stratatech, a Mallinckrodt Company at 4 sites in United States.
Trial summary
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma-related Wound, Burns, Skin Wound
- 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
- 3 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Apr 2017to 26 Mar 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years, inclusive
- Written informed consent
- Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
- Total skin defect may consist of more than one wound area
- Full-thickness complex skin defects requiring excision and autografting
- Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
- For thermal burns only, first excision and grafting of treatment sites
Who cannot join
- Pregnant women and prisoners
- Subjects receiving systemic immunosuppressive therapy
- Subjects with a known history of malignancy
- Preadmission insulin-dependent diabetic subjects
- 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
Show all 13Show fewer
- Participation in the treatment group of an interventional study within the 90 days prior to enrollment
- Chronic wounds
- The face, head, neck, hands, feet, buttocks, perineum, and area over joints
- Treatment sites with exposed tendon or bony prominences
- Chemical and electrical burns
- Treatment sites adjacent to unexcised eschar
- Clinical suspicion of infection at the anticipated treatment sites
Trial locations and contacts
4 sites in 1 country.
United States4 sites
U.S. Army Institute of Surgical Research Adult Burn Center
Fort Sam Houston, Texas, 78234-6315
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Arizona Burn Center
Phoenix, Arizona, 85008
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
Read the detailed description
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.
- Conditions
- Trauma-related Wound, Burns, Skin Wound
- Being tested
- StrataGraft Skin Tissue, Autograft
- Keywords
- Full-thickness, Acute trauma
- 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 complex skin defects. 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 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 the StrataGraft Treatment Site Requiring Autografting by Three Months
The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
Measured: 3 months
Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
Measured: 3 months
Secondary outcomes (6)
Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
Measured: within 3 months
Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
Measured: within 3, 6 and 12 months
Percent Wound Closure at 3, 6, and 12 Months
Measured: within 3, 6, and 12 Months
Cosmesis of Treatment Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Measured: within 3, 6, and 12 Months
Cosmesis of Donor Sites at 3, 6, and 12 Months
Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Measured: within 3, 6, and 12 Months
Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
Measured: at days 3, 7, 14, 21, and 28
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 start24 Apr 2017
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Why it stopped: Protracted enrollment and limited wound closure in the first three subjects
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 Trauma-related 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- See detailed description
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005054
- Sponsor's protocol ID
- STRATA2014
- Other IDs
- W81XWH-16-C-0202
- Status last verified
- Jul 2021
- First submitted
- 21 Dec 2016
- Last updated
- 3 Aug 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 (NCT03005054) 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
- ClinicalTrials.gov ID
- NCT03005054
- Acronym / sponsor ID
- STRATA2014
- Conditions
- Trauma-related Wound, Burns, Skin Wound
- Keywords
- Full-thickness, Acute trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protracted enrollment and limited wound closure in the first three subjects
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
Detailed description
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.
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 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 18-65 years, inclusive
- Written informed consent
- Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
- Full-thickness complex skin defects requiring excision and autografting
Key exclusion criteria (13 listed)
- Pregnant women and prisoners
- Subjects receiving systemic immunosuppressive therapy
- Subjects with a known history of malignancy
- Preadmission insulin-dependent diabetic subjects
- Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or 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 |
|---|---|---|
| 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 complex skin defects. 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 wound. | Procedure or surgery | StrataGraft skin tissue |
Primary outcome
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
Time frame: 3 months
The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
Time frame: 3 months
Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
6 secondary outcomes
Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
Time frame: within 3 months
Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
Time frame: within 3, 6 and 12 months
Percent Wound Closure at 3, 6, and 12 Months
Time frame: within 3, 6, and 12 Months
Cosmesis of Treatment Sites at 3, 6, and 12 Months
Time frame: within 3, 6, and 12 Months
Cosmesis of Donor Sites at 3, 6, and 12 Months
Time frame: within 3, 6, and 12 Months
Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
Time frame: at days 3, 7, 14, 21, and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 (NCT03005054) 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.
Study Director study director
Mallinckrodt
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing StrataGraft Skin Tissue and Autograft in people with Trauma-related Wound and Burns, run by Stratatech, a Mallinckrodt Company at 4 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Aug 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 the StrataGraft Treatment Site Requiring Autografting by Three Months (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?
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 3 Aug 2021.