Clinical experience with a full-thickness placental allograft (NeoThelium FT) in chronic venous leg ulcers: A prospective single-arm study
DOI:
https://doi.org/10.63676/8typkz85Keywords:
Leg ulcer, Allografts, Chronic wounds, placental allograftAbstract
Background: Venous leg ulcers (VLUs) present a significant challenge in healthcare, afflicting millions of patients and generating substantial economic strain on healthcare systems. A multitude of studies have been performed to evaluate the effectiveness of placental allografts in the treatment of chronic wounds. Randomized controlled trials support placental allografts as a class in VLUs; however, published clinical data on full-thickness products that retain the intermediate layer remain limited.
Methods: This prospective case series encompassed 8 patients, 5 male and 3 female, with chronic, lower extremity VLUs that received weekly applications of NeoThelium FT placental allograft. Although officially categorized as a dehydrated dual-layer amnion/chorion wound sheet, due to the conservation of the intermediate and spongy layers, NeoThelium FT can more broadly be described as a full-thickness allograft.
Results: In the presented case series, the average initial wound area was 4.96 cm2. The cohort reached an average percent area reduction – calculated from aggregate wound area – of 79.32% by the 12th application, with 6 of 8 participants achieving complete wound closure.
Conclusion: The findings of this study indicate that NeoThelium FT may be associated with favorable healing outcomes when incorporated as a treatment modality for patients with chronic VLUs.
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The research data supporting the findings of this study are stored internally and are available upon reasonable request for evaluation. Inquiries may be directed to the corresponding author.
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