Third Degree BurnPhase 1/2NCT00618839
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
A Phase 1/2 study testing StrataGraft Skin Tissue and Cadaver allograft in people with Third Degree Burn and Burns, run by Stratatech, a Mallinckrodt Company at 2 sites in United States.
Trial summary
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third Degree Burn, Burns, Wound Infection
- What is being tested?
- StrataGraft Skin Tissue and Cadaver allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Apr 2008
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged greater than 18 yrs.
- Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
- Full-thickness skin defects
- Informed consent
Who cannot join
- Prisoners
- Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
- Immunosuppressive therapy
- Infection with Human Immunodeficiency Virus
- Venous stasis ulcers of the lower leg
- Diabetic foot ulcers
Show all 16Show fewer
- Donor site wounds
- Wounds of less than 5% body surface area
- Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)
- Prior entry into this study
- Expected survival of less than 3 months
- Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)
- Use of an investigational agent within 30 days
- Active malignancy
- Clinical evidence of malnutrition
- Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin-Hospital and Clinics
Madison, Wisconsin, 53792
Arizona Burn & Trauma Center
Phoenix, Arizona, 85008
About this study
Official title: Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
This pilot Phase I/II clinical study will be conducted at up to three clinical sites.
This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Read the detailed description
Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debridement and temporary wound coverage with biological dressing prior to autografting. The specific objectives of this phase I/IIa clinical trial were to assess the safety of StrataGraft skin tissue using a predetermined panel of clinical and laboratory endpoints and assess the efficacy of StrataGraft skin tissue by comparing the ability of StrataGraft skin tissue to the standard of care, human cadaver skin, to condition complex skin defects for subsequent autografting. In three cohorts of five patients each, the maximum amount of StrataGraft skin tissue applied to excised full-thickness skin wounds was increased sequentially from 0.5% to 1.0%, and then to 1.5% TBSA. Equivalent study wound areas on each subject were treated with StrataGraft or cadaver allograft for one week, at which time the allograft tissues were removed and the wound bed was evaluated. Infection and appearance of the temporary allogeneic skin tissue were evaluated at every study session until autograft placement. The wound was covered with split-thickness skin autografts when the wound was judged ready to accept an autograft. Autograft take was assessed two weeks after autograft placement.
- Conditions
- Third Degree Burn, Burns, Wound Infection, Degloving Injury
- Being tested
- StrataGraft Skin Tissue, Cadaver allograft
- Keywords
- Complex skin defects, Burns, Wound infection, Skin trauma
- Medical subject headings
- Burns, Wound Infection, Degloving Injuries
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 circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells).
Cadaver allograftProcedure or surgery
The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.
| Study group | Role | What they receive |
|---|---|---|
| StrataGraft : cadaver allograft | Experimental | All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design Receives: Biological: StrataGraft Skin Tissue; Procedure: Cadaver allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
Measured: two weeks post-autografting
Secondary outcomes (2)
Appearance of Allograft Tissues
The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).
Measured: StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.
Viability of Allograft Tissues
Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.
Measured: At the time of allograft removal (~7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionApr 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for Third Degree 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Stratatech, Inc., a Mallinckrodt Pharmaceeuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618839
- Sponsor's protocol ID
- STRATA2001
- Other IDs
- R44AR047499
- Status last verified
- Dec 2018
- First submitted
- 7 Feb 2008
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar;66(3):866-73; discussion 873-4. doi: 10.1097/TA.0b013e31819849d6.
PubMed 19276766Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Ann Surg. 2011 Apr;253(4):672-83. doi: 10.1097/SLA.0b013e318210f3bd.
PubMed 21475006
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
- Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures
- ClinicalTrials.gov ID
- NCT00618839
- Acronym / sponsor ID
- STRATA2001
- Conditions
- Third Degree Burn, Burns, Wound Infection, Degloving Injury
- Keywords
- Complex skin defects, Burns, Wound infection, Skin trauma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 10 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot Phase I/II clinical study will be conducted at up to three clinical sites.
This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Detailed description
Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debridement and temporary wound coverage with biological dressing prior to autografting. The specific objectives of this phase I/IIa clinical trial were to assess the safety of StrataGraft skin tissue using a predetermined panel of clinical and laboratory endpoints and assess the efficacy of StrataGraft skin tissue by comparing the ability of StrataGraft skin tissue to the standard of care, human cadaver skin, to condition complex skin defects for subsequent autografting. In three cohorts of five patients each, the maximum amount of StrataGraft skin tissue applied to excised full-thickness skin wounds was increased sequentially from 0.5% to 1.0%, and then to 1.5% TBSA. Equivalent study wound areas on each subject were treated with StrataGraft or cadaver allograft for one week, at which time the allograft tissues were removed and the wound bed was evaluated. Infection and appearance of the temporary allogeneic skin tissue were evaluated at every study session until autograft placement. The wound was covered with split-thickness skin autografts when the wound was judged ready to accept an autograft. Autograft take was assessed two weeks after autograft placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StrataGraft : cadaver allograft | Experimental | Biological: StrataGraft Skin Tissue, Procedure: Cadaver allograftAll patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged greater than 18 yrs.
- Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
- Full-thickness skin defects
- Informed consent
Key exclusion criteria (16 listed)
- Prisoners
- Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
- Immunosuppressive therapy
- Infection with Human Immunodeficiency Virus
- Venous stasis ulcers of the lower leg
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 circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells). | Biological | StrataGraft : cadaver allograft |
| Cadaver allograftThe standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted. | Procedure or surgery | StrataGraft : cadaver allograft |
Primary outcome
Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.
Time frame: two weeks post-autografting
The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.
2 secondary outcomes
Appearance of Allograft Tissues
Time frame: StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.
Viability of Allograft Tissues
Time frame: At the time of allograft removal (~7 days)
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.
- Results publication: PubMed 19276766Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar;66(3):866-73; discussion 873-4. doi: 10.1097/TA.0b013e31819849d6.
- Results publication: PubMed 21475006Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Ann Surg. 2011 Apr;253(4):672-83. doi: 10.1097/SLA.0b013e318210f3bd.
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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 Pharmaceeuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing StrataGraft Skin Tissue and Cadaver allograft in people with Third Degree Burn and Burns, run by Stratatech, a Mallinckrodt Company at 2 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 4 inclusion and 16 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 2 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 combined 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.
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 10 Sep 2012). 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 Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. (time frame: two weeks post-autografting). 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 NCT00618839, which also lists 2 linked publications.
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.