Thermal InjuryPhase 2NCT01655407
Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
A Phase 2 study testing Autologous Engineered Skin Substitute and Split-Thickness Autograft (AG) in people with Thermal Injury and Deep Partial-Thickness Burn, run by Amarantus BioScience Holdings, Inc. at 3 sites in United States.
Trial summary
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds. The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Thermal Injury, Deep Partial-Thickness Burn, Full-Thickness Burn
- What is being tested?
- Autologous Engineered Skin Substitute and Split-Thickness Autograft (AG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites.
- Is expected to require multiple skin grafting procedures.
- Is ≥18 years and ≤40 years of age at the time of enrollment.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day.
- Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed.
Who cannot join
- Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study.
- Has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- Is pregnant.
- Is a prisoner at the time of obtaining written informed consent.
- Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin.
- Has a documented history of allergy or sensitivity to any of the animal products used in preparation of ESS-W. These products include bovine blood, bovine collagen, bovine collagenase, and porcine trypsin-versene.
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- Has a documented history of allergy or sensitivity to glycosaminoglycan, the polymer component of ESS-W.
- Has a documented ongoing condition which could delay wound healing such as insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C).
- Has a severe malnutrition or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
US Army Institute of Surgical Research
Houston, Texas, 78234
Ian Driscoll, MD, 210-916-3301, ian.r.driscoll.mil@mail.mil
Ian Driscoll, MD
Arizona Burn Center
Pheonix, Arizona, 85008
Kevin N Foster, MD, FACS, 602-344-5624, kevin_foster@dmgaz.org
Kevin N Foster, MD, FACS
Harborview Medical Center
Seattle, Washington, 98104
Nicole Gibran, 206-744-3140, nicoleg@uw.edu
Nicole Gibran
About this study
Official title: Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.
The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.
Read the detailed description
This study is designed to evaluate the safety and efficacy of autologous engineered skin substitute (ESS-W) compared to conventional split-thickness AG for the treatment of extensive, deep partial- and full-thickness thermal burns. A matched and randomized burn site format will be used to evaluate the successful graft take on excised deep partial- and full-thickness burns when grafted with either 1) unmeshed ESS-W or 2) meshed AG (the current standard treatment of split thickness AG).
This research study is divided into five study periods: (1) Screening Period of up to one week and (2) Pre-Grafting Period, which will last approximately 35-45 days, (3) Grafting Day(s), which are the day(s) on which grafts are applied (i.e., First Graft: Day 0 and the optional subsequent Grafting Day i.e., Second Graft: Day 0), (4) Post Grafting Observation Period, which begins with 28 days follow-up after each Grafting Day(s), and continues till Post-Operative Month (POM) 6 from the last Grafting Day, and (5) Anecdotal Observation Period
- Being tested
- Autologous Engineered Skin Substitute, Split-Thickness Autograft (AG)
- Keywords
- Split-thickness Autograft, Engraftment, Wound Closure, Engineered Skin Substitute, ESS-W, Cultured Skin Substitutes, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Engineered Skin SubstituteDrug
Also called ESS-W
The total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.
ESS-W will be applied to the appropriate recipient site, according to the randomization schedule, by the surgeon using two pairs of forceps. Sufficient ESS-W sheets will be used to cover the recipient site. The ESS-W grafts will be stapled in place.
Split-Thickness Autograft (AG)Drug
Also called Split-thickness skin grafts (STSGs)
The total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.
The AG regimen occurs in stages, beginning with excision of the burned skin, followed by temporary wound coverage (e.g. cadaveric skin allografts, porcine xenograft, synthetic or biologic dressings or medical devices) to achieve wound homeostasis, and completed by permanent wound closure using autologous skin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). Receives: Drug: Autologous Engineered Skin Substitute; Drug: Split-Thickness Autograft (AG) |
| Control | Active comparator | All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). Receives: Drug: Autologous Engineered Skin Substitute; Drug: Split-Thickness Autograft (AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of infections at grafting sites
Assessments will be done on the following days/months:
- Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 and Month 6 after the last grafting day.
Measured: Up to Month 6 after the last grafting day
Incidence of re-grafting
Assessments will be done on the following days/months:
- Post operative Day 7, Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 and Month 6 after the last grafting day.
Measured: Up to Month 6 after the last grafting day
Incidence of adverse events that are related to study treatment and associated with the grafting site
Assessments will be done on the following days/months:
- Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day.
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Incidence of all adverse events.
Assessments will be done on the following days/months:
- Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day.
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Percentage engraftment as determined by the Investigator through clinical assessment
Assessments will be done on the following days/months:
- Post operative Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 after the last grafting day
Measured: Up to Month 3 after the last grafting day
Percentage engraftment as determined by an independent observer through clinical assessment
Assessments will be done on the following days/months:
- Post operative Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 after the last grafting day
Measured: Up to Month 3 after the last grafting day
Confirmation of engraftment by histological assessment
Assessments will be done on the following days/months:
- Post Operative Month 3 and Month 6 after the last grafting day
Measured: Up to Month 6 after the last grafting day
Percentage of wound closure as determined by blinded computerized planimetric assessment
Assessments will be done on the following days/months:
- Post operative Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 after the last grafting day
Measured: Up to Month 3 after the last grafting day
Percentage area of re-grafting as determined by blinded computerized planimetric assessment
Assessments will be done on the following days/months:
- Post operative Day 7, Day 14 and Day 28 after each grafting day.
- Post Operative Month 3 and Month 6 after the last grafting day.
Measured: Up to Month 6 after the last grafting day
Secondary outcomes (5)
Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).
Assessments will be done on the following days/months:
- Post operative Day 28 after each grafting day.
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument
Assessments will be done on the following days/months:
- Post operative Day 14 and Day 28 after each grafting day.
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Incidence of contracture release or revision surgeries
Assessments will be done on the following days/months:
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity
Assessments will be done on the following days/months:
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Incidence of paresthesias, pain, dulling of sensation assessed through patient self-reporting scale and by monofilament testing
Assessments will be done on the following days/months:
- Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Measured: Up to Month 36 after the last grafting day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startSep 2016
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amarantus BioScience Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Michael Peck, MD, Study director, The Arizona Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655407
- Sponsor's protocol ID
- Lonza-ESS01
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients
- ClinicalTrials.gov ID
- NCT01655407
- Acronym / sponsor ID
- Lonza-ESS01
- Keywords
- Split-thickness Autograft, Engraftment, Wound Closure, Engineered Skin Substitute, ESS-W, Cultured Skin Substitutes, Burn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Amarantus BioScience Holdings, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.
The areas of the body that are treated with ESS-W will be compared to similar areas treated with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG) will be performed by taking healthy skin from one area of the body and placing it on the burned area.
Detailed description
This study is designed to evaluate the safety and efficacy of autologous engineered skin substitute (ESS-W) compared to conventional split-thickness AG for the treatment of extensive, deep partial- and full-thickness thermal burns. A matched and randomized burn site format will be used to evaluate the successful graft take on excised deep partial- and full-thickness burns when grafted with either 1) unmeshed ESS-W or 2) meshed AG (the current standard treatment of split thickness AG).
This research study is divided into five study periods: (1) Screening Period of up to one week and (2) Pre-Grafting Period, which will last approximately 35-45 days, (3) Grafting Day(s), which are the day(s) on which grafts are applied (i.e., First Graft: Day 0 and the optional subsequent Grafting Day i.e., Second Graft: Day 0), (4) Post Grafting Observation Period, which begins with 28 days follow-up after each Grafting Day(s), and continues till Post-Operative Month (POM) 6 from the last Grafting Day, and (5) Anecdotal Observation Period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Autologous Engineered Skin Substitute, Drug: Split-Thickness Autograft (AG)All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). |
| Control | Active comparator | Drug: Autologous Engineered Skin Substitute, Drug: Split-Thickness Autograft (AG)All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has deep partial or full-thickness thermal burns ≥50% of the TBSA and fulfills the total grafting area requirement ranging from 288 cm2 up to 5,600 cm2, divided between two (or more) recipient sites.
- Is expected to require multiple skin grafting procedures.
- Is ≥18 years and ≤40 years of age at the time of enrollment.
- Females of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use appropriate birth control methods during the pre-grafting period and for three months following the last Grafting Day.
- Subject (or a legally authorized representative (LAR)) has provided written informed consent for study participation and procedures to be performed.
Key exclusion criteria (9 listed)
- Has a current diagnosis of septic shock or Multiple Organ Dysfunction Syndrome, which in the opinion of the Investigator would put the potential subject at risk of serious morbidity or death by participating in the study.
- Has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- Is pregnant.
- Is a prisoner at the time of obtaining written informed consent.
- Has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of ESS-W including the irrigation solution used before and after grafting. These include aminoglycosides, polymyxin B, mupirocin, ciprofloxacin, amphotericin B, hydrocortisone, and insulin.
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 |
|---|---|---|
| Autologous Engineered Skin SubstituteAlso: ESS-WThe total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG. ESS-W will be applied to the appropriate recipient site, according to the randomization schedule, by the surgeon using two pairs of forceps. Sufficient ESS-W sheets will be used to cover the recipient site. The ESS-W grafts will be stapled in place. | Drug | Control, Treatment |
| Split-Thickness Autograft (AG)Also: Split-thickness skin grafts (STSGs)The total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG. The AG regimen occurs in stages, beginning with excision of the burned skin, followed by temporary wound coverage (e.g. cadaveric skin allografts, porcine xenograft, synthetic or biologic dressings or medical devices) to achieve wound homeostasis, and completed by permanent wound closure using autologous skin. | Drug | Control, Treatment |
Primary outcome
Incidence and severity of infections at grafting sites
Time frame: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
Incidence of re-grafting
Time frame: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
Incidence of adverse events that are related to study treatment and associated with the grafting site
Time frame: Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Incidence of all adverse events.
Time frame: Up to Month 36 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 1 - Day 6, Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3, Month 6, Month 12, Month 24 and Month 36 after the last grafting day
Percentage engraftment as determined by the Investigator through clinical assessment
Time frame: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Percentage engraftment as determined by an independent observer through clinical assessment
Time frame: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Confirmation of engraftment by histological assessment
Time frame: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: - Post Operative Month 3 and Month 6 after the last grafting day
Percentage of wound closure as determined by blinded computerized planimetric assessment
Time frame: Up to Month 3 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 14 and Day 28 after each grafting day. * Post Operative Month 3 after the last grafting day
Percentage area of re-grafting as determined by blinded computerized planimetric assessment
Time frame: Up to Month 6 after the last grafting day
Assessments will be done on the following days/months: * Post operative Day 7, Day 14 and Day 28 after each grafting day. * Post Operative Month 3 and Month 6 after the last grafting day.
5 secondary outcomes
Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).
Time frame: Up to Month 36 after the last grafting day
Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument
Time frame: Up to Month 36 after the last grafting day
Incidence of contracture release or revision surgeries
Time frame: Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity
Time frame: Up to Month 36 after the last grafting day
Incidence of paresthesias, pain, dulling of sensation assessed through patient self-reporting scale and by monofilament testing
Time frame: Up to Month 36 after the last grafting day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Michael Peck, MD study director
The Arizona Burn Center
3 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 Autologous Engineered Skin Substitute and Split-Thickness Autograft (AG) in people with Thermal Injury and Deep Partial-Thickness Burn, run by Amarantus BioScience Holdings, Inc. at 3 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kush Dhody, MBBS, MSc ((301) 956-2536, kushd@amarexcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of infections at grafting sites (time frame: Up to Month 6 after the last grafting day). The study lists 9 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 31 Aug 2016.