A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects with Deep Partial Thickness (DPT) Thermal Burns

Date Added
April 10th, 2023
PRO Number
Pro00125082
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

To evaluate whether StrataGraft treatment promotes wound closure and reduces or
eliminates the need for donor site harvest and autografting in a pediatric population with thermal burns that contain intact dermal elements and for which autografting would be part of standard of care (deep partial-thickness [DPT] burns). Study assessments will include the incidence of adverse events (AEs), including wound
infection, and additionally monitoring of vital signs, clinical laboratory values, immunological values (where possible), wound closure, including any autografting, and skin quality of the treatment site.

Institution
MUSC
Recruitment Contact
Courtney Tresslar
843-792-0325
tresslar@musc.edu

A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns

Date Added
July 6th, 2021
PRO Number
Pro00109484
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.

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

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



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