Efficay and Safety Evaluation of Kedrion Fibrin Sealant, in middle ear microsurgery. Monocenter, controlled, single blind, randomised, two parallel arms, phase II/III study - Fibrin sealant in middle ear microsurgery

• Conditions: Chronic otitis; MedDRA version: 14.0Level: PTClassification code 10033081Term: Otitis media chronicSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2010-023991-15-IT
• Lead Sponsor: KEDRIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy.;Secondary Objective: Efficacy evaluation of IMP for: <br>1. deficit auditive recovery <br>2. topic therapy.<br>Safety and tollerability evaluation of IMP;Primary end point(s): To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy.