First clinical data demonstrating PuraStat’s safety and efficacy for haemostasis in thyroidectomy and parathyroidectomy. A case series of 353 patients.
Cervical endocrine surgeries such as thyroidectomy and parathyroidectomy can carry the risk of severe bleeding complications. In these cases, stopping the bleeding could be tricky and energy-based devices are avoided due to the proximity to the nerves.
In the publication “The use of self-assembling peptides (PuraStat) for haemostasis in cervical endocrine surgery. A real-life case series of 353 patients” (IJSCR, 2022) by Dr. Yves Gangner, Dr. M. Bagot d’Arc and C. Delin, the authors explored the efficacy and safety of PuraStat, a haemostatic topical hydrogel, in cervical endocrine surgery.
The 353 patients underwent thyroidectomy and/or parathyroidectomy and PuraStat was applied at the end of the procedure in contact with parathyroid glands and recurrent nerves.
The results were as follows:
- Only 0.84 % of the patients showed hematoma within 24h: this rate of bleeding complications falls within the low ranges found in the literature.
- There were no delayed bleeds, no seroma and no local surgical site infections, which are usually observed in 1 to 7% of cases.
- This is the first study with PuraStat in cervical endocrine surgery and showed high performance and safety in achieving haemostasis and in preventing bleeding without damage to the recurrent nerves.
This clinical data is valuable evidence regarding the use of PuraStat for haemostasis in other specialities where close attention is required due to the proximity to the nerves (i.e. Urology-radical prostatectomy, etc.).
PuraStat is indicated for “achieving haemostasis in bleeding from small blood vessels and oozing from capillaries of the parenchyma and surrounding tissues of solid organs when haemostasis by ligation or conventional means is insufficient or impractical".
You can read the full publication [here].