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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
KCT0000305 |
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Date of registration:
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29/12/2011 |
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Primary sponsor: |
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Public title:
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The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients
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Scientific title:
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The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients |
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Date of first enrolment:
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2011-04-22 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1674 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Single, Blinding Target : Subject, Allocation : RCT
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Chan Hum
Park |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hallym University Chuncheon Sacred Heart Hospital |
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Name:
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Ji Heui
Kim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hallym University Chuncheon Sacred Heart Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A(No Limit)
Age maximum:
N/A(No Limit)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the ear and mastoid process
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Intervention(s)
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Device : In the patients with traumatic tympanic membrane perforations or non-infectious chronic otitis media, a classic local anesthesia is done under the operative microscope. The rim of the perforation is carefully trimmed using a Rosen needle and a cup forceps, to encourage migration of the mucosal layer and the epithelium. The silk fibroin patch or paper patch is moistened with ointment to ensure its adherence to the tympanic membrane.
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Primary Outcome(s)
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Healing rate of tympanic membrane perforation
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Secondary Outcome(s)
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Complication
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Healing times of tympanic membrane perforation
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Hearing improvement
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Infection rate
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Source(s) of Monetary Support
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