A Randomized Controlled Trial Comparing the Success Rate of Fresh and Dried Temporalis Fascia in Myrigoplasty in Patient With Perforated Tympanic Membrane Due to Chronic Otitis Media
We performed this randomized clinical trial in order to compare the prognosis and hearing outcomes of those patients with chronic otitis media, aged between 15 and 60, undergoing myringoplasty using wet (soft) or dry (rigid) temporalis fascia. All patients had perforated Tympanic Membrane with no other ear problems. Patient with Cholesteatoma, granulation tissue and tympanic sclerotic plaque in middle ear were excluded from the trial.
This was a randomized double-blind clinical trial being performed in Shahid Dastgheib Hospital of Shiraz University of Medical Sciences during a 1–year period including 233 ears undergoing dry (n=116) or wet (n=117) temporalis fascia myringoplasty. The mean speech reception threshold (SRT) and speech-discrimination scores (SDS), air conduction (AC) and bone conduction (BC) at 250, 500, 1000, 2000, 3000 and 4000 Hz as well as Air-Bone Gap (ABG) were recorded and compared between two surgical methods.In this trial, the patients and the physician that followed and examined them after operation were blinded to type of graft that had been used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102411249N1
Registration date:2014-02-11, 1392/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Hossein Hamedi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1629 1478
Email address
hamediho@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
no
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Controlled Trial Comparing the Success Rate of Fresh and Dried Temporalis Fascia in Myrigoplasty in Patient With Perforated Tympanic Membrane Due to Chronic Otitis Media
Public title
Fresh and Dried Temporalis Fascia in Myrigoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the 15 to 60 years old patients that have perforated T.M due to COM; Dry and normal ear mucosa and normal ossicles; Have no other disease.
Exclusion criteria: Underlying disease such as: D.M; renal failure; Active COM; Cholesteatoma; granulation tissue and tympanic sclerotic plaque in middle ear; Age: <15 y/o or >60 y/o ; Smokers; Ossicular fixation and/or disruption
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
233
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of medical Sciences
Street address
Zand Blvd.
City
Shiraz
Postal code
Approval date
2011-12-29, 1390/10/08
Ethics committee reference number
CT-P-90-1774
Health conditions studied
1
Description of health condition studied
Perforation of tympanic membrane
ICD-10 code
H72.9
ICD-10 code description
Perforation of tympanic membrane, unspecified
Primary outcomes
1
Description
Tympanic Membrane Repair
Timepoint
before intervention ,3 and 6 months after intervention
Method of measurement
Examination
2
Description
air conducting and bone conducting hearing threshold
Timepoint
before intervention, 3 and 6 months after intervention
Method of measurement
audiometry
Secondary outcomes
1
Description
Air-Bone Gap
Timepoint
before intervention,3 and 6 months after intervention
Method of measurement
audiometry
Intervention groups
1
Description
Myringoplasty using dried temporalis fascia. In this method after harvesting temporalis fascia, we let the fascia dry in the room temperature for about 10 minutes . the technique that we used to put the graft in its places was underlay technique.
Category
Treatment - Surgery
2
Description
Myringoplasty using fresh temporalis fascia. In this method we used the graft right after harvesting temporalis fascia. the technique that we used to put the graft in its places was underlay technique.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Datgheib Hospital
Full name of responsible person
Dr Abolhassan Faramarzi
Street address
Hafez Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Abolhassan Faramarzi
Position
Associate Professor
Other areas of specialty/work
Street address
Dastgheib Hospital
City
Shiraz
Postal code
Phone
+98 71 1629 1478
Fax
Email
faramarzi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abolhassan Faramarzi
Position
Associate Professor
Other areas of specialty/work
Street address
Dastgheib hospital
City
Shiraz
Postal code
Phone
+98 71 1629 1478
Fax
Email
faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Mosleh Shirazi
Position
Ear, Nose and throat resident
Other areas of specialty/work
Street address
Khalili Hospital, Khalili street
City
Shiraz
Postal code
Phone
+98 71 1629 1470
Fax
Email
maryamosleh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)