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

NCT01655407 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-08-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Amarantus BioScience Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Peck, MD · The Arizona Burn Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-12-31
Completion
2020-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655407 on ClinicalTrials.gov