Skin WoundPhase 1NCT01437852
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
A Phase 1 study testing StrataGraft Skin Tissue in people with Skin Wound and Burns, run by Stratatech, a Mallinckrodt Company at 6 sites in United States.
Trial summary
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Wound, Burns, Trauma-related Wound
- What is being tested?
- StrataGraft Skin Tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2011to Oct 2014
- Phase
- Phase 1
- 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 designated as a donor site in the event that the StrataGraft treatment site requires autografting
- Complex skin defects of 3-49% TBSA requiring excision and autografting
- Total burn may consist of more than one wound area
- Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting
- First excision and grafting of treatment sites
Who cannot join
- Pregnant women and prisoners
- Patients receiving systemic immunosuppressive therapy
- Patients with a known history of malignancy
- Preadmission insulin-dependent diabetic patients
- Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
- Expected survival of less than three months
Show all 12Show fewer
- Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment
- Full-thickness burns will be excluded as treatment sites
- Chronic wounds will be excluded as treatment sites
- The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites
- Treatment sites adjacent to unexcised eschar
- Clinical suspicion of burn wound infection at the anticipated treatment sites
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Hospital Burn Center
Aurora, Colorado, 80045
UT-Southwestern Medical Center
Dallas, Texas, 75390-9158
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-6315
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Maricopa Integrated Health Systems, Arizona Burn Center
Phoenix, Arizona, 85008
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Being tested
- StrataGraft Skin Tissue
- 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
| Study group | Role | What they receive |
|---|---|---|
| StrataGraft skin tissue | Experimental | All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio.
Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting 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 Wound Closure of the Treatment Sites at Three Months
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Measured: 3 months
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2014
- Study completionOct 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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, Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437852
- Sponsor's protocol ID
- STRATA2011
- Other IDs
- WFUHS 40269
- Status last verified
- Dec 2018
- First submitted
- 19 Sep 2011
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting
- ClinicalTrials.gov ID
- NCT01437852
- Acronym / sponsor ID
- STRATA2011
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StrataGraft skin tissue | Experimental | Biological: StrataGraft Skin TissueAll subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18-65 years, inclusive
- Written informed consent
- Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting
- Complex skin defects of 3-49% TBSA requiring excision and autografting
- Total burn may consist of more than one wound area
Key exclusion criteria (12 listed)
- Pregnant women and prisoners
- Patients receiving systemic immunosuppressive therapy
- Patients with a known history of malignancy
- Preadmission insulin-dependent diabetic patients
- Patients with concurrent conditions that in the opinion of the investigator may compromise patient 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 Tissue | Biological | StrataGraft skin tissue |
Primary outcome
Number of Participants With Wound Closure of the Treatment Sites at Three Months
Time frame: 3 months
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
Time frame: 28 days
The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing StrataGraft Skin Tissue in people with Skin Wound and Burns, run by Stratatech, a Mallinckrodt Company at 6 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 12 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Dec 2018). 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 Wound Closure of the Treatment Sites at 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 16 Oct 2019.