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

NCT03333941 | Completed Results FDA Device

• 1 other identifier: CTP001-8
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Wound Healing

  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)

Study Arms (1)

RES (Regenerative Epithelial Suspension)

Device: ReCell® Autologous Cell Harvesting Device

Interventions

ReCell® Autologous Cell Harvesting Device DEVICE

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

RES (Regenerative Epithelial Suspension)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Burn Unit

You may qualify if:

• 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.
• Area(s) requiring skin grafting at least 320 square centimeters.
• 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.

You may not qualify if:

• 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.
• Pregnant or lactating women.

Sponsors & Collaborators

• Avita Medical: lead
• Advanced Clinical Research Services, LLC: collaborator

Study Sites (6)

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, Arizona, 85008, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103-3409, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: VP Clinical Research
• Organization: AVITA Medical

clinicaltrial@avitamedical.com

661-367-9710

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 7, 2017
• Study Start: October 26, 2017
• Primary Completion: December 19, 2018
• Study Completion: May 8, 2019
• Last Updated: July 30, 2024
• Results First Posted: July 19, 2021

Record last verified: 2024-07

Locations

US (6)