Use of NexoBrid for Treatment of Acute deep partial and full thickness Burn Injuries

Date Added
March 24th, 2020
PRO Number
Pro00095953
Researcher
Steven Kahn

List of Studies

Keywords
Surgery
Summary

This is an Expanded Access (treatment) protocol to expand treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study). This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from deep partial thickness (DPT) and full thickness (FT) thermal burns. Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient's DPT and FT burns that comply with the entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will allow an evaluation of the patient's systemic safety by allowing treatment of the patient's entire deep burns. Patients enrolled in this trial will undergo daily vital signs and pain assessments for 1 week starting on the morning after the start of treatment. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed. There will also be a scar quality evaluation at 3 and 12 months post wound closure confirmation visit.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared with the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1 – 16 Years)

Date Added
January 13th, 2020
PRO Number
Pro00092124
Researcher
Steven Kahn

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Surgery
Summary

The purpose of the study is to see if use of the RECELL device will help heal your
partial-thickness burn faster and decrease the need for skin grafting compared with a standardized wound dressing. The data collected in this current study will provide additional information about the safety and effectiveness of the RECELL® device for treatment of partial-thickness burns. The duration of each participant will last up to 12 months. Visits will include photograph documentation of the wound and various health assessments.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu



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