ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-26

Study Completion Date

2017-02-01

Brief Summary

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This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).

Study Groups

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All Participants (within patient control)

All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Group Type EXPERIMENTAL

ReCell Treatment

Intervention Type DEVICE

Skin Graft

Intervention Type PROCEDURE

Interventions

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ReCell Treatment

Intervention Type DEVICE

Skin Graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
5. Life expectancy is less than 1 year.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No