The overall purpose of this study is to evaluate the safety of the CellMist™ System in the treatment of deep second degree burns (II°B) in a prospective, multicenter, feasibility pilot study.
Patients between the ages of 18 and 65 years of age inclusive with a ≤ 30% Total Body Surface Area (TBSA) that requires surgical or enzymatic debridement and split thickness skin grafting (STSG) on any body surface excluding the face, joints, perineum and hands will be considered for participation in this study. CellMist™ solution (autologous epidermal and dermal cells) will be administered, via the System Skin Gun™, will be evenly distributed to aid in burn healing. Healing, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning safety of the CellMist™ System will be collected. Safety will be evaluated in terms of treatment and serious related adverse events. Each subject will participate in up to 9 total visits (screening, treatment and 7 follow-up study visits) over a period of 52 weeks. Up to 14 subjects will be enrolled and treated within this at up to 4 institutions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Open Label, Safety and Feasibility
Washington MedStar Hospital
Washington D.C., District of Columbia, United States
All Adverse Events
All Adverse Events will be reported, recorded and analyzed which occur from the time Informed Consent is given through the conclusion of the study. We will be looking at ; Incidence, Severity, Expectedness, Duration, Treatment, and the Relationship to Device for each Adverse Event reported.
Time frame: We will be evaluating all adverse events reported for the period from enrollment through the final visit which will be 12 months
Secondary Surgical Interventions
We will be evaluating and analyzing all secondary surgical interventions required to treat the intended target wound. A secondary surgical intervention may include debridement, biopsy, identification of an infectious pathogen, split thickness skin graft, etc...
Time frame: The evaluation will include all reported secondary surgical interventions for the period from enrollment and up to 12 months
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