The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery. A real-life case series of 353 patients
Abstract
Introduction Cervical endocrine surgery is frequent and carries the risk of rare but potentially life-threatening bleeding complications. Energy-based devices for stopping bleeding are not always usable in contact with nerves or parathyroid glands. Topical hemostatic agents may be an additional resource. PuraStat™, made of the self-assembling peptide RADA16, forms a new category of topical hemostatic agents. Objective To assess the performance and safety of PuraStat to achieve hemostasis in cervical endocrine surgery. Methods A retrospective chart review over four years was performed on 353 patients undergoing thyroidectomy and/or parathyroidectomy by a single senior surgeon, using PuraStat at the end of surgery in contact with recurrent nerves and parathyroid glands. Results 353 patients (79.06% female, mean age 54 years) underwent surgery with six weeks follow-up visit. Three patients had revision surgery for hematoma within the first 4 h (0.84%), which is within the low ranges reported in the literature. There was no delayed bleeding after 24 h, and dysphonia was observed in 15 patients, more severe for 2 patients (one unilateral and one bilateral palsy), and transient for the other 13 patients suggesting no product-related damage to the recurrent nerves. Hypocalcemia with clinical signs were reported in 8 cases. There were no unexpected adverse events. Conclusion This is the first report of the use of PuraStat in patients undergoing cervical endocrine surgery, showing…
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