NCT01138917

A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Avita Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.

Conditions

• Burns

Interventions

Type	Name	Description
DEVICE	ReCell and Split-thickness skin graft	The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.

Timeline

• Start date: 2010-05-21
• Primary completion: 2014-08-29
• Completion: 2015-08-26
• First posted: 2010-06-08
• Last updated: 2019-05-13
• Results posted: 2019-05-13

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study