Skip to main content
OpenTrials
Completed

NCT Number: NCT02994654

CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burns Wounds and Injuries

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Burn Center at Maricopa Integrated Health Systems, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • The area of total burn injury is 5-50% TBSA inclusive.
  • Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
  • The subject is at least 5 years of age.
  • The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
  • The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
  • The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  • The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion criteria

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

Treatment and study plan

ReCell

Device

The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.

The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.

Primary outcomes

  1. Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)

    Time frame: Prior to or at 8 weeks

    Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.

  2. Relative Reduction in Donor Skin Area Requirement

    Time frame: Prior to or at 8 weeks

    For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.

Sponsors and collaborators

Lead sponsor

Avita Medical

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 16, 2016
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.