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

NCT ID: NCT01655407

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-07-31

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

Conditions

Thermal Injury; Deep Partial-Thickness Burn; Full-Thickness Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).

Group Type: EXPERIMENTAL

Autologous Engineered Skin Substitute

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Control

All patients will receive both Autologous Engineered Skin Substitute (ESS-W) and Split-Thickness Autograft (AG).

Group Type: ACTIVE_COMPARATOR

Autologous Engineered Skin Substitute

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ESS-W; Split-thickness skin grafts (STSGs)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amarex Clinical Research

OTHER

Sponsor Role: collaborator

Amarantus BioScience Holdings, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Peck, MD

Role: STUDY_DIRECTOR

The Arizona Burn Center

Locations

Arizona Burn Center

Pheonix, Arizona, United States

US Army Institute of Surgical Research

Houston, Texas, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Central Contacts

Kush Dhody, MBBS, MSc

Role: CONTACT

kushd@amarexcro.com

(301) 956-2536

Facility Contacts

Kevin N Foster, MD, FACS

Role: primary

kevin_foster@dmgaz.org

602-344-5624

Ian Driscoll, MD

Role: primary

ian.r.driscoll.mil@mail.mil

210-916-3301

Nicole Gibran

Role: primary

nicoleg@uw.edu

206-744-3140

Other Identifiers

Lonza-ESS01

Identifier Type: -

Identifier Source: org_study_id