Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Lonza Walkersville, Inc.
Sponsor:
Collaborator:
Amarex Clinical Research, LLC.
Information provided by (Responsible Party):
Lonza Walkersville, Inc.
ClinicalTrials.gov Identifier:
NCT01655407
First received: July 20, 2012
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Thermal Injury
Deep Partial-Thickness Burn
Full-Thickness Burn
Drug: Autologous Engineered Skin Substitute
Drug: Split-Thickness Autograft (AG)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lonza Walkersville, Inc.:

Primary Outcome Measures:
  • Incidence and severity of infections at grafting sites [ Time Frame: Up to Month 6 after the last grafting day ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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). [ Time Frame: Up to Month 36 after the last grafting day ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to Month 36 after the last grafting day ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to Month 36 after the last grafting day ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to Month 36 after the last grafting day ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to Month 36 after the last grafting day ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 10
Study Start Date: July 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
Drug: Autologous Engineered Skin Substitute

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.

Other Name: ESS-W
Drug: Split-Thickness Autograft (AG)

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.

Other Name: Split-thickness skin grafts (STSGs)
Active Comparator: Control
All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).
Drug: Autologous Engineered Skin Substitute

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.

Other Name: ESS-W
Drug: Split-Thickness Autograft (AG)

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.

Other Name: Split-thickness skin grafts (STSGs)

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655407

Contacts
Contact: Kush Dhody, MBBS, MSc (301) 956-2536 kushd@amarexcro.com

Locations
United States, Arizona
Arizona Burn Center Not yet recruiting
Pheonix, Arizona, United States, 85008
Contact: Kevin N Foster, MD, FACS    602-344-5624    kevin_foster@dmgaz.org   
Principal Investigator: Kevin N Foster, MD, FACS         
United States, Texas
US Army Institute of Surgical Research Not yet recruiting
Houston, Texas, United States, 78234
Contact: Ian Driscoll, MD    210-916-3301    ian.r.driscoll.mil@mail.mil   
Principal Investigator: Ian Driscoll, MD         
United States, Washington
Harborview Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Nicole Gibran    206-744-3140    nicoleg@u.washington.edu,   
Principal Investigator: Nicole Gibran         
Sponsors and Collaborators
Lonza Walkersville, Inc.
Amarex Clinical Research, LLC.
Investigators
Study Director: Michael Peck, MD The Arizona Burn Center
  More Information

No publications provided

Responsible Party: Lonza Walkersville, Inc.
ClinicalTrials.gov Identifier: NCT01655407     History of Changes
Other Study ID Numbers: Lonza-ESS01
Study First Received: July 20, 2012
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Lonza Walkersville, Inc.:
Split-thickness Autograft
Engraftment
Wound Closure
Engineered Skin Substitute
ESS-W
Cultured Skin Substitutes
Burn

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 30, 2015