임상연구정보서비스

The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients

Status Approved

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0000305
Unique Protocol ID	PJ007676032011
Public/Brief Title	The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients
Scientific Title	The clinical study of patch graft using silk patch in the traumatic drum perforation and non-infectious chronic otitis media patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2010-11-779
Approval Date	2011-04-06
Institutional Review Board Name	Institutional Review Board of Hallym University Kangnam Sacred Heart Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Chan Hum Park
Title	M.D., Ph.D.
Telephone	+82-33-240-5181
Affiliation	Hallym University Medical Center- Chuncheon
Address
Contact Person for Public Queries
Name	Ji Heui Kim
Title	M.D.
Telephone	+82-33-240-5181
Affiliation	Hallym University Medical Center- Chuncheon
Address
Contact Person for Updating Information
Name	Ji Heui Kim
Title	M.D.
Telephone	+82-33-240-5181
Affiliation	Hallym University Medical Center- Chuncheon
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2011-04-22
Target Number of Participant	60
Primary Completion Date	2012-06-30 , Anticipated
Study Completion Date	2012-06-30 , Anticipated
Name of Study	Hallym University Medical Center- Chuncheon
Recruitment Status	Recruiting
Date of First Enrollment	2011-05-06 ,
Recruitment Status by Participating Study Site 2
Name of Study	Hallym University Medical Center-Kangnam
Recruitment Status	Recruiting
Date of First Enrollment	2011-04-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Rural Development Administration
Organization Type	Government
Project ID	PJ007676032011

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hallym University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	To investigate the effects of a thin silk patch in patients with traumatic tympanic membrane perforations or non-infectious chronic otitis media compared with the commonly used paper patch

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	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.
Number of Arms	2
Arm 1	Arm Label SF patch
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description The silk fibroin patch is placed on the lateral surface of the TM making sure that it completely covered the perforation and that it was in close contact with its entire margin.
Arm 2	Arm Label Paper patch
	Target Number of Participant 30
	Arm Type Active comparator
	Arm Description The paper patch is placed on the lateral surface of the TM making sure that it completely covered the perforation and that it was in close contact with its entire margin.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H72.9)Perforation of tympanic membrane, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description (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
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Healing rate of tympanic membrane perforation
Timepoint	Postoperative 2 months
Secondary Outcome(s) 1
Outcome	Infection rate
Timepoint	Postoperative 2 months
Secondary Outcome(s) 2
Outcome	Hearing improvement
Timepoint	Postoperative 2 months
Secondary Outcome(s) 3
Outcome	Healing times of tympanic membrane perforation
Timepoint	Postoperative 2 months
Secondary Outcome(s) 4
Outcome	Complication
Timepoint	Postoperative 2 months

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration