Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03333941|
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
|Condition or disease||Intervention/treatment|
|Burns||Device: ReCell® Autologous Cell Harvesting Device|
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.
|Study Type :||Observational|
|Actual Enrollment :||76 participants|
|Official Title:||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|
|Actual Study Start Date :||October 26, 2017|
|Actual Primary Completion Date :||December 19, 2018|
|Actual Study Completion Date :||May 8, 2019|
|RES (Regenerative Epithelial Suspension)||
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.
- Wound Healing [ Time Frame: 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333941
|United States, Arizona|
|Arizona Burn Center at Maricopa Integrated Health Systems|
|Phoenix, Arizona, United States, 85008|
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|United States, Louisiana|
|University Medical Center|
|New Orleans, Louisiana, United States, 70112|
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Tennessee|
|University of Tennessee Health Science Center|
|Memphis, Tennessee, United States, 38103-3409|