Chronic otitis MedDRA version: 14.0 Level: PT Classification code 10033081 Term: Otitis media chronic System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Fibrin Sealant
Pharmaceutical Form: Sealant
INN or Proposed INN: Combinations
Concentration unit: mg milligram(s)
Concentration number: 60-
Sponsors
KEDRION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. Ear Microsurgery for middle simple chronic otitis; 3. The subjects or their authorised legal representatives must have received all necessary information as regards the nature of the clinical study, they must agree with the purpose of the study and must have signed and dated the informed consent form approved by the EC. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Use of other adhesive/sealant agents; 2.Presence of conditions that, at the discretion of the Investigator, may interfere with the assessment of the study’s purpose or with participation in the study; 3. Previous use of products with aprotinine bovine (less than 12 months); 4. Known allergies to one or more components (aprotinin) of the IMP and/or other blood derivatives; 5. Concomitant debilitating deseases (diabetes, immunological and ematological deseases); 6.Missing written consent form required for participation in the study; 7.Participation in another clinical study in the month preceding the start of the study (i.e. in the last 30 days, the subject has taken other trial drugs); 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy.;Secondary Objective: Efficacy evaluation of IMP for: 1. deficit auditive recovery 2. topic therapy. Safety and tollerability evaluation of IMP;Primary end point(s): To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy. | — |
Countries
Italy
Outcome results
None listed