DRKS00017739Completed未知
Monocenter clinical investigation to evaluate safety and performance of Geistlich Mucograft® for soft tissue augmentation after removal of intraoral tumors
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Geistlich Pharma AG
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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