Obsidian® ASG Autologous Platelet-Rich Fibrin Matrix for the prevention of postoperative pancreatic fistula following pancreatic resection –A feasibility pilot trial - Obsidian - pilot trial

Medizinische Universität Wien0 个研究点目标入组 25 人开始时间: 2024年5月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Scheduled for elektive partial pancreatic resection, due to any underlying disease.

•Inclusion criteria comprise =18 years of age, ability to understand character and individual consequences of the clinical trial, as well as written informed consent. For patients with childbearing potential, presence of preoperative negative urine or negative blood pregnancy test and adequate contraception until 14 days after trial intervention is required. Patients with severe systemic disease that is a constant threat to life, classified as American Society of Anaesthesiologists’ (ASA) score >3 and patients with known hypersensitivity to any component in the formulation will be excluded as will be patients with understanding or language problems and patients with inability to comply with the study and/or follow-up procedures. Pregnant and breast-feeding patients as well as patients with concurrent participation in another interventional clinical trial with interference with the trial outcome will also be excluded.

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