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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

NCT02994654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-30

Study results available
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Summary

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.

Conditions

  • Burns

Interventions

DEVICE

ReCell

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.

Sponsors & Collaborators

  • Avita Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2018-09-30

Countries

  • United States

Study Locations

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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 NCT02994654 on ClinicalTrials.gov