NCT03333941

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Avita Medical · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Burns

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-26
• Primary completion: 2018-12-19
• Completion: 2019-05-08
• First posted: 2017-11-07
• Last updated: 2024-07-30
• Results posted: 2021-07-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study