This randomized prospective study will be carried out on patients who underwent tympanoplasty and mastoidectomy. The patients who complied with the study criteria will be randomly assigned to receive a wet graft or a dry graft. The study consists of 40 ears which will be assigned into the following groups. Audio-tympanometry will be done for all the patients and all the operations will be performed under general anesthesia, using a post-auricular approach. The temporalis fascia of the patients undergoing the dry graft procedure will be immediately removed after the post-auricular incision. It will be then placed and spread between glass plates and dried until it becomes rigid. The temporalis fascia of the patients undergoing the wet graft operation will be removed and spread between glass plates immediately before placing graft. Before the placement of the graft, using the underlay technique, the samples of both wet and dry grafts will be taken for histological examination. All the patients received postoperative oral antibiotics for10 days. The deep external auditory canals will be cleared of serosanguinous collections and an absorbable gelatin sponge. Graft condition will be assessed in that time by an examiner, who is blind of graft type, using autoscope or microscope.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012294455N2
Registration date:2011-02-06, 1389/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-06, 1389/11/17
Registrant information
Name
Samad Ghiasi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 3886
Email address
ghiasis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-12-31, 1389/10/10
Expected recruitment end date
2011-03-01, 1389/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tympanoplasty success in draining ear by using wet or dry fascia
Public title
Tympanoplasty success in draining ear by using wet or dry fascia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age at least 12 years old, indication of middle ear surgery and tympanic membrane surgery, Draining ear after medical therapy, Interest for corporation in this study, Referring to Oto-rhinolaryngology and Head and Neck Surgery, clinic in Imam Reza (Training and Research Hospital), follow-up for a minimum period of 2 months
Exclusion criteria: previous middle ear surgery, ears tumor with chronic granular myringitis, presence of cancer, diabetes mellitus, or renal failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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, Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Daneshgah Street
City
Tabriz
Postal code
Approval date
2010-12-30, 1389/10/09
Ethics committee reference number
8948
Health conditions studied
1
Description of health condition studied
Chronic otitis media
ICD-10 code
H71
ICD-10 code description
Cholesteatoma of middle ear
Primary outcomes
1
Description
Success rate
Timepoint
2 months
Method of measurement
exammination-observation
Secondary outcomes
1
Description
microscopic appearance
Timepoint
A few days after surgery
Method of measurement
Microscopic examination
Intervention groups
1
Description
The temporalis fascia of patients undergoing the dry graft procedure will be removed immediately after the postauricular incision. It will be then placed and spread between glass plates and dried until it becomes rigid.
Category
Treatment - Surgery
2
Description
The temporalis fascia of patients undergoing the wet graft operation will be removed and spread between glass plates immediately before placing graft.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Training and Research Hospital
Full name of responsible person
Dr Samad Ghiasi, Assistant Professor of ENT
Street address
ENT ward - Imam Reza hospital- Golgasht
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Ali Meshkini
Street address
Medical School, Tabriz University Of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samad Ghiasi
Position
Assistant Professor
Other areas of specialty/work
Street address
ENT ward, Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
ghiasis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Saman Vegari
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT ward, Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)