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.
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.
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.