Investigating the effect of split-thickness skin grafts on the acceleration of mastidectomy repair along with lowering the posterior wall and comparing it with the control group.
Determining the effect of using skin graft in accelerating mastoidectomy repair by lowering the canal wall and comparing it with the control group.
Design
A clinical trial with a control group with parallel groups, double-blind, simple, randomized, using closed envelopes on 50 patients.
The rand function of Excel software was used for randomization.
Settings and conduct
Cholestoma patients in Qaim and Imam Reza Hospital of Mashhad who needed tympanomastoidectomy and CWD (canal wall down)were divided into 2 groups.
that in the intervention group, in addition to cwd, STSG was also implanted in the mastoid cavity
In this study, except for the surgeon who was not blinded, the rest of the people were blind to the type of group
Participants/Inclusion and exclusion criteria
Inclusion criteria: All cholesteatoma patients who have not yet undergone ear surgery and need CWD surgery
Exclusion criteria: Patients who have brain and nerve complications or have a history of previous surgery
Intervention groups
Intervention: Cholestoma patients who underwent CWD surgery with STSG implantation in the mastoid cavity.
Control: Cholestoma patients who underwent CWD surgery without STSG implantation
Investigating the effect of split-thickness skin grafts on the acceleration of mastidectomy repair along with lowering the posterior wall and comparing it with the control group.
Public title
Investigating the effect of STSG on Cholesteatoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Cholesteatoma
Exclusion criteria:
Revision surgery
Cns complication
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who are candidates to enter the plan after obtaining consent using closed envelopes, choose one based on group A and group B, who will undergo cwd surgery alone or cwd along with stsg.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were blinded to which group they entered, and patients were told that they could undergo only normal surgery or with stsg.
The researcher and the author of the article are blinded to which group A and B belong to the intervention group
There was no possibility of blinding the surgeon due to the form of the study, but the evaluations after the operation were performed by a person who was blinded to the patient group.
The statistical analyzer was also blinded to the groups
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
East door of university campus, Azadi square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١٩١٧٧٨
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.096
Health conditions studied
1
Description of health condition studied
Cholesteatoma
ICD-10 code
H71.2
ICD-10 code description
Cholesteatoma of mastoid
Primary outcomes
1
Description
Mastoid cavity repair rate
Timepoint
One month and 3 months later
Method of measurement
Examination of the ear under a microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cholestoma patients who undergo mastoidectomy and CWD surgery, at the end of the operation, stsg is removed from the skin behind the canal and expanded in the mastoid cavity.
Category
Treatment - Surgery
2
Description
Control group: Cholestoma patients who undergo mastoidectomy and CWD surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital of Mashhad
Full name of responsible person
Dr mohammadreza afzal zadeh
Street address
Ghaem hospital, Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad medical universty,Vakil abad street
City
mashhad
Province
Razavi Khorasan
Postal code
9137913131
Phone
+98 51 3879 5031
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Dr mohammadreza akhoundian yazd
Position
Ent resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
akhoundianm911@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr mohammadreza afzal zadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital ,Ahmad abad street
City
Mashhhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
afzalzadehmr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Dr mohammadreza akhoundian yazd
Position
Ent resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
akhoundianm911@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available