NuScience Medical Biologics, LLC
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity 3. Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection 4. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit 5. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion 6. Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg 7. Pressure Injury/Ulcer is treated with offlo…
NeoThelium 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.
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