Monocenter clinical investigation to evaluate safety and performance of Geistlich Mucograft® for soft tissue augmentation after removal of intraoral tumors

Geistlich Pharma AG0 个研究点目标入组 8 人开始时间: 2019年8月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Written informed consent; Age 18 years or older; Intraoral tumor up to size T2; Acute mucosa defect after a surgical excision of an intraoral tumor (primary diagnosis) with a total defect size (i.e. tumor plus resection margin) of maximum 12cm2

•General contraindications for surgical treatments; Allergy to porcine collagen; Autoimmune disease; Patients with local tumor recurrence; Previous radiation in head and neck area; Planned radiation therapy before day 28 of this clinical investigation; Planned chemotherapy during this clinical investigation; Insulin dependent diabetes; Previous or planned high dosed corticosteroid, or immunosuppression therapy; Heavy smoking defined as more than 20 cigarettes per day; Acute infection in the oral cavity; Known disease of the connective tissue; Known or suspected non-compliance or drug abuse; Alcohol abuse defined as more than: For women: 2 drinks (20g alcohol) per day on more than 5 days/week, For men: 4 drinks (40g alcohol) per day on more than 5 days/week; Inability to follow the procedures of the clinical investigation; Vulnerable population; Women of childbearing age who are not using a highly effective method of birth control; Pregnant or breast feeding women; Participation in another clinical investigation with investigational drug, biologics or device within the 26 weeks preceding the present clinical investigation; Participation in another clinical investigation during the present clinical investigation

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