The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients
Not Applicable
Recruiting
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0000305
- Lead Sponsor
- Hallym University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
(1) Traumatic tympanic membrane perforation
- Tympanic membrane perforation is caused by trauma within 2 weeks
(2) Non-infectious chronic otitis media
- The treated ears is free from infections and dry for at least 3 months before the patch application
Exclusion Criteria
(1) evidence of middle ear disease or active drainage
(2) chronic mastoiditis
(3) uncooperative patients
(4) patients disagree with this study
(5) more than 75% perforation
(6) perforation including tympanic annulus, malleus umbo
(7) disruption of the ossicles
(8) allergy to silk fibroin
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing rate of tympanic membrane perforation
- Secondary Outcome Measures
Name Time Method Infection rate ;Hearing improvement ;Healing times of tympanic membrane perforation ;Complication