Back to resultsSafety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
Primary Purpose
Thermal Injury, Deep Partial-Thickness Burn, Full-Thickness Burn
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous Engineered Skin Substitute
Split-Thickness Autograft (AG)
Sponsored by
About this trial
This is an interventional treatment trial for Thermal Injury focused on measuring Split-thickness Autograft, Engraftment, Wound Closure, Engineered Skin Substitute, ESS-W, Cultured Skin Substitutes, Burn
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Arizona Burn Center
- US Army Institute of Surgical Research
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
Outcomes
Primary Outcome Measures
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.
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.
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
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
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
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
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
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
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.
Secondary Outcome Measures
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
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
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
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
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
Full Information
NCT ID
NCT01655407
First Posted
July 20, 2012
Last Updated
August 29, 2016
Sponsor
Amarantus BioScience Holdings, Inc.
Collaborators
Amarex Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT01655407
Brief Title
Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amarantus BioScience Holdings, Inc.
Collaborators
Amarex Clinical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 (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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermal Injury, Deep Partial-Thickness Burn, Full-Thickness Burn
Keywords
Split-thickness Autograft, Engraftment, Wound Closure, Engineered Skin Substitute, ESS-W, Cultured Skin Substitutes, Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
Intervention Type
Drug
Intervention Name(s)
Autologous Engineered Skin Substitute
Other Intervention Name(s)
ESS-W
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Split-Thickness Autograft (AG)
Other Intervention Name(s)
Split-thickness skin grafts (STSGs)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence and severity of infections at grafting sites
Description
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.
Time Frame
Up to Month 6 after the last grafting day
Title
Incidence of re-grafting
Description
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.
Time Frame
Up to Month 6 after the last grafting day
Title
Incidence of adverse events that are related to study treatment and associated with the grafting site
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Incidence of all adverse events.
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Percentage engraftment as determined by the Investigator through clinical assessment
Description
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
Time Frame
Up to Month 3 after the last grafting day
Title
Percentage engraftment as determined by an independent observer through clinical assessment
Description
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
Time Frame
Up to Month 3 after the last grafting day
Title
Confirmation of engraftment by histological assessment
Description
Assessments will be done on the following days/months:
- Post Operative Month 3 and Month 6 after the last grafting day
Time Frame
Up to Month 6 after the last grafting day
Title
Percentage of wound closure as determined by blinded computerized planimetric assessment
Description
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
Time Frame
Up to Month 3 after the last grafting day
Title
Percentage area of re-grafting as determined by blinded computerized planimetric assessment
Description
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.
Time Frame
Up to Month 6 after the last grafting day
Secondary Outcome Measure Information:
Title
Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Incidence of contracture release or revision surgeries
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Incidence of increased temperature sensitivity
Description
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
Time Frame
Up to Month 36 after the last grafting day
Title
Incidence of paresthesias, pain, dulling of sensation assessed through patient self-reporting scale and by monofilament testing
Description
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
Time Frame
Up to Month 36 after the last grafting day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kush Dhody, MBBS, MSc
Phone
(301) 956-2536
Email
kushd@amarexcro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Peck, MD
Organizational Affiliation
The Arizona Burn Center
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Burn Center
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin N Foster, MD, FACS
Phone
602-344-5624
Email
kevin_foster@dmgaz.org
First Name & Middle Initial & Last Name & Degree
Kevin N Foster, MD, FACS
Facility Name
US Army Institute of Surgical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Driscoll, MD
Phone
210-916-3301
Email
ian.r.driscoll.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Ian Driscoll, MD
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Gibran
Phone
206-744-3140
Email
nicoleg@uw.edu
First Name & Middle Initial & Last Name & Degree
Nicole Gibran
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
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