1. Home
  2. Approved trials
  3. » فارسی

Clinical application of an amniotic membrane in canal wall down tympanomastoidectomy

Protocol summary

Summary
Aim of this study was comparison of clinical application of an amniotic membrane in canal wall down tympanomastoidectomy in adults regarding primary outcomes. This was a double blind randomized clinical study in a single center in Dastgheib University Hospital (Shiraz-Iran). Audiologist and statistician as assessors were blind. Patients divided in two groups; amniotic membrane (75 patients) and control group (75 patients). Inclusion criteria were: all patients more than 18 years old, canal wall down mastoidectomy because of choronic otitis media with choleastetoma, final size of tympanic membrane perforation more than 50%. Exclusion criteria were: revision surgery, pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder and chronic liver or renal disease, patients without adequate follow up (less than 6 months), canal wall down mastoidectomy because of other reason such as tumors. Primary outcomes were otorrhea, granulation tissue, epithelialization, tympanic membrane graft successes rate and hearing results at least six months was compared within two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081915496N16
Registration date: 2017-05-07, 1396/02/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-07, 1396/02/17
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical application of an amniotic membrane in canal wall down tympanomastoidectomy
Public title
Clinical application of embryonic membrane in middle ear surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients more than 18 years old; canal wall down mastoidectomy because of choronic otitis media with choleastetoma; final size of tympanic membrane perforation more than 50%. Exclusion criteria: revision surgery; pre operative medical problems such as asthma, diabetes, coagulation disorders, cardiovascular disease, basic metabolic disorder and chronic liver or renal disease; patients without adequate follow up (less than 6 months); canal wall down mastoidectomy because of other reason such as tumors.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
IR.SUMS.MED.REC.1396.13

Health conditions studied

1

Description of health condition studied
choronic otitis media with choleasteaoma
ICD-10 code
H66.2,H66.
ICD-10 code description
Chronic atticoantral suppurative otitis media, Other chronic suppurative otitis media,Suppurative otitis media, unspecified,Chronic mastoiditis

Primary outcomes

1

Description
tympanic membrane graft successes rate
Timepoint
within 6 months after surgery
Method of measurement
Observation by physician

2

Description
epithelialization
Timepoint
within 6 months after surgery
Method of measurement
Observation by physician

3

Description
otorrhea
Timepoint
within 6 months after surgery
Method of measurement
Observation by physician

4

Description
existance granulation tissue
Timepoint
within 6 months after surgery
Method of measurement
Observation by physician

5

Description
hearing threshold
Timepoint
before operation -6 months after operation
Method of measurement
pure tone audiometry

Secondary outcomes

empty

Intervention groups

1

Description
The aminiotic membrane used for coverage of muscle flap in intervention group.
Category
Treatment - Surgery

2

Description
The aminiotic membrane did not used for coverage of muscle flap in control group.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Mohammad Faramarzi
Street address
Hafez Street, Next to National Garden
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street
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 of 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
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3629 1478
Fax
Email
Roosta.Sareh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faramarzi
Position
Associate Professor of Otolaryngology
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
00
Fax
Email
Faramarzi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
Fax
Email
Roosta.Sareh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...