Study on PuraStat's Efficacy in Liver Resection Bleeding Now Published
New clinical trial data with PuraStat is now available in the publication “A multi-centre post-market clinical study to confirm safety and performance of PuraStat in the management of bleeding during open liver resection” by Dr. Christopher B. Nahm and Prof. Giles J. Toogood in HPB journal (Elsevier, 2021).
The trial, sponsored by 3-D Matrix Europe SAS, recruited N=80 patients in different centres around Europe (UK, Romania, Germany, and Spain), undergoing elective liver resection for hepatic metastases and treated with PuraStat. PuraStat was used to stop persistent oozing/bleeding when haemostasis by ligation or other standard means were insufficient or impractical.
91.7% of bleeding sites reached complete haemostasis after the application of PuraStat. The mean time to haemostasis (TTH) per treated site was 51 seconds. Ease of use of the product was described as either “excellent” or “good” in 98.8% patients. Two properties of PuraStat that were identified as the best features of the product by the doctors during the surgical procedures were its transparency, and the ability to use the product repeatedly during the same procedure.
PuraStat is indicated for “achieving haemostasis in bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs”1.
The study showed and confirmed the safety, efficacy, and ease of use of PuraStat in liver resection procedures as a powerful agent in the management of bleeding in liver surgery.
1PuraStat IFU-007 Rev 2
To read the full publication, click here.