A multi-center post-market clinical study to confirm safety and performance of PuraStat® in the management of bleeding during open liver resection.

Abstract

BACKGROUND\nPuraStat® is a non-bioactive haemostatic agent that has demonstrated efficacy in a number of different surgical procedures. We performed a prospective multi-centre post-market study to evaluate the efficacy and safety of PuraStat® in liver resections performed for metastatic tumors.\n\n\nMETHODS\nThis was a prospective cohort study. Patients undergoing liver resection for metastatic tumor were screened for eligibility, and included if they were ≥18 years old, undergoing open liver resection, had normal liver function, and required application of PuraStat® for haemostasis where standard haemostatic techniques were either insufficient or impractical. The primary endpoint was time to haemostasis (TTH). Secondary endpoints included blood loss, total postoperative drainage volume, transfusion of blood products, and ease of use.\n\n\nRESULTS\nEighty patients were included for analysis in the intention to treat population. 207 bleeding sites were treated with PuraStat. Of these, 190 (91.7%) bleeding sites reached haemostasis after PuraStat® application. Mean TTH (mm:ss) was 1:01 (SD 1:06, range 0:09-6:55). Ease of use of the product was described as either excellent or good in 78 (98.8%) patients. No serious adverse events were identified.\n\n\nCONCLUSION\nThis study confirms the safety, efficacy and ease of use of PuraStat® in the management of bleeding in liver surgery.