PuraStat® is a new synthetic haemostatic agent constituting peptides that self-assemble into sheets when exposed to ionic charges. The objective of this submission is to assess the perioperative, functional and user-reported outcomes of PuraStat® as an athermal topical haemostatic agent for use on the neurovascular bundle (NVB) in robot-assisted radical prostatectomy (RARP), and to inform further research into this developing field.
Demographic and disease data for 29 consecutive patients undergoing RARP were recorded. PuraStat® was used as the primary haemostatic agent to the NVB, without thermal or suture haemostasis, unless necessary. Preoperative, 1-h postoperative and 24-h postoperative haemoglobin (Hb) were measured. Operative data including postoperative complications up to 30 days were noted. Urinary function, continence and erectile function (EF) were measured pre- and postoperatively with the International Prostate Symptom Score (IPSS), patient reporting of pad usage, and International Index of Erectile Function (IIEF)-5 respectively. A qualitative assessment of PuraStat® was made intraoperatively by the surgical assistant in the following categories: transparency, haemostatic efficacy, ready-to-use, handling, and overall satisfaction.
Twenty-nine males aged between 49 and 75 years underwent a nerve-sparing RARP under a single surgeon for clinically significant prostate cancer with PuraStat® used as the primary haemostatic agent at the NVB. One patient required an additional haemostatic suture. The median prostate volume was 36 mL. Mean blood loss was 363 mL. The mean Hb at 1 and 24 h postoperative was 135.2 and 125.1 mg/dL. Median Hb change from 1-24 h postoperative was 11 mg/dL. No transfusions were required, and there were no postoperative complications. Urinary function and continence were preserved. EF in our series was lower than published data.
Our observational study suggests that PuraStat® is a safe haemostatic agent in RARP with similar perioperative bleeding outcomes, comparable long-term urinary outcomes and a high level of intraoperative user satisfaction. The effects on EF requires further investigation. PuraStat® appears to be a useful therapeutic tool for the urologist performing RARPs.
Translational andrology and urology. 2023 Nov 06 [Epub]
Kale Munien, William Harrison, Joshua Paul, Devang Desai
Department of Urology, Toowoomba Specialists, Queensland, Australia.