Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

July 24, 2023 updated by: Avita Medical

Continued Access Protocol: A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared With the ReCell® Device Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.

Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.

It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Arizona Burn Center at Maricopa Integrated Health Systems
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38103-3409
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Burn Unit

Description

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. Area(s) requiring skin grafting at least 320 square centimeters.
  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 follow-up 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. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RES (Regenerative Epithelial Suspension)
RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Wound Healing
Time Frame: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2017

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

May 8, 2019

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP001-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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