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

NCT03333941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2024-07-30

Study results available
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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

Interventions

DEVICE

ReCell® Autologous Cell Harvesting 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.

Sponsors & Collaborators

  • Advanced Clinical Research Services, LLC

    collaborator OTHER

  • Avita Medical

    lead INDUSTRY

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2018-12-19
Completion
2019-05-08
FDA Device
Yes

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 NCT03333941 on ClinicalTrials.gov