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StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

NCT03005106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-07-14

Study results available
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Summary

About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.

The burns will:

* be on 3-49% of the participant's total body surface area (TBSA)
* require surgery for skin replacement
* include intact dermal elements

The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.

The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.

All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.

This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.

Conditions

  • Burn, Thermal

Interventions

BIOLOGICAL

StrataGraft Skin Tissue

StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).

PROCEDURE

Autograft

The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.

Sponsors & Collaborators

  • Stratatech, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Stratatech, a Mallinckrodt Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-07-31
Completion
2020-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03005106 on ClinicalTrials.gov