C06.0
Conditions
Interventions
Group 1: Geistlich Mucograft
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound epithelialization at day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Assessment of Adverse Events Effectiveness: (I) Wound epithelialization after 7, 14, 21, 90 days post-surgery; (ii) Adapted POSAS score at 28 and 90 days post-surgery; (iii) Oral mucosa contraction/shortening measured at 0, 28 and 90 days post-surgery; (iv) Patient overall satisfaction 90 days post-surgery | — |
Countries
Germany
Contacts
Public ContactMichael Homm
Geistlich Pharma AG
Outcome results
None listed