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

NCT01655407 | Unknown Phase 2 DMC

• 1 other identifier: Lonza-ESS01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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

  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

  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

  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

  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

  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

  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.

  Up to Month 6 after the last grafting day

Secondary Outcomes (5)

• Scar outcome assessment using the modified Vancouver Scar Scale (mVSS).

  Up to Month 36 after the last grafting day

• Incidence and severity of post-burn pruritus utilizing a validated patient self-assessment instrument

  Up to Month 36 after the last grafting day

• Incidence of contracture release or revision surgeries

  Up to Month 36 after the last grafting day

• Incidence of increased temperature sensitivity

  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

  Up to Month 36 after the last grafting day

Study Arms (2)

Treatment

EXPERIMENTAL

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

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).

Drug: Autologous Engineered Skin Substitute; Drug: Split-Thickness Autograft (AG)

Interventions

Autologous Engineered Skin Substitute 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.

Also known as: ESS-W

Control; Treatment

Split-Thickness Autograft (AG) 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.

Also known as: Split-thickness skin grafts (STSGs)

Control; Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amarantus BioScience Holdings, Inc.: lead
• Amarex Clinical Research: collaborator

Study Sites (3)

Arizona Burn Center

Pheonix, Arizona, 85008, United States

Location

US Army Institute of Surgical Research

Houston, Texas, 78234, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michael Peck, MD

  The Arizona Burn Center

  STUDY DIRECTOR

Central Study Contacts

Kush Dhody, MBBS, MSc

CONTACT

(301) 956-2536; kushd@amarexcro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 1, 2012
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

US (3)