Evaluating the efficacy and safety of Neothelium FT placental allograft in the management of hard-to-heal open wounds: a prospective case series.

OBJECTIVE: The aetiology of hard-to-heal (chronic) wounds is usually categorised as either 'diabetic foot', 'venous leg ulcer (VLU)', 'arterial', 'pressure injury', 'postoperative' and 'other'. Due to the homogeneity of patients with a diabetic foot ulcer, the majority of studies regarding the efficacy of placental allografts have been in this population of patients, with a small fraction conducted with patients with VLUs. However, insufficient research has been performed regarding advanced modalities for the treatment of other, open hard-to-heal wounds resulting from alternative aetiologies, such as trauma or failed surgical procedures. The aim of this case series was to evaluate the efficacy and safety of a placental allograft in the treatment of hard-to-heal VLUs.

METHOD: This prospective case series encompassed patients with hard-to-heal open wounds on various parts of their body and who received weekly applications of a placental allograft (Neothelium FT, Surgenex, LLC., US). Wound surface area was measured weekly prior to each application of the placental allograft to quantify wound size and calculate percent area reduction (PAR).

RESULTS: A total of 10 patients-three males and seven females- were included. Mean initial wound area was 11.98cm2. Of the eight patients who achieved complete healing (80% closure rate), the average number of allograft applications was 5.13 (median: 5). The patients demonstrated an average PAR of 87.48% by study completion.

CONCLUSION: The findings of this study suggest that the placental allograft used may offer an effective treatment option for patients with hard-to-heal open wounds.