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 a randomized study to evaluate the clinical performance of RECELL for re-pigmentation of stable, de-pigmented skin in subjects 18 years or older. RECELL is a device that takes a small sample of skin from one location on the participant's body, processes that sample into a spray, and then applies that spray to the depigmented skin on the participant's body. Each participant will have some depigmented skin that is not treated by the RECELL device, so that a comparison can be made to the treated areas. The participant will be asked to return for a follow-up visit 1, 4, 12, 24, 36, and 52 weeks after their treatment, so that the research study team can assess their outcome.
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.