This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity
Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
Subject has a known life expectancy of <1 year
Subject is unable to comply with protocol treatment
Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing in the opinion of the investigator
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
Single group
NeoThelium FT (HCT/P 361)
Other interventionNeoThelium FT (HCT/P 361) is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Complete Wound Closure
Complete wound closure (100% epithelialization without drainage)
Percent Area Reduction
Percent area reduction of wounds at 16 weeks compared to initial baseline measurement (performed using standardized methods of wound area measurement)
Wound Closure
Evaluate wounds remaining closed for the 2 week follow
Number of Grafts
Average number of grafts/weeks used to achieve wound closure
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NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator
