Investigating the effect of using autologous platelet factor in accelerating mastoidectomy repair with removal of the posterior wall and comparing it with the control group.
The use of autologous platelet factor in accelerating CWD mastoidectomy recovery and comparison with the control group
Design
The clinical trial has a control group with parallel groups, a single-blind, randomized phase 2-3 using sealed envelope, single-center and includes 50 patients.
Settings and conduct
This single-blind randomized controlled clinical trial (the participants in the study are blinded) in the ENT department of Imam Reza Hospital, Mashhad, on 50 patients for mastoidectomy. Eligible patients are divided into control and intervention groups after obtaining consent. In the control group, only Gelfoam will be used, but in the intervention group, in addition to Gelfoam, 4 to 8 cc of throat fibrin enriched with platelets are used. which is located in the area inside the middle ear below and above.
Participants/Inclusion and exclusion criteria
Patient satisfaction and performing mastoidectomy operation by removing the posterior wall and not suffering from anemia and no complications during the operation
Intervention groups
In the control group, only 4 to 8 cc of Gelfoam will be used, but in the intervention group, in addition to Gelfoam, 4 to 8 cc of throat fibrin enriched with platelets (Blood Transfusion Organization of Iran, Mashhad, Iran) would be used, which is placed inside the middle ear.
Main outcome variables
The duration of epithelialization of the eardrum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211010052721N3
Registration date:2022-10-22, 1401/07/30
Registration timing:retrospective
Last update:2022-10-22, 1401/07/30
Update count:0
Registration date
2022-10-22, 1401/07/30
Registrant information
Name
Navid nourizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
nourizadehn@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2022-01-20, 1400/10/30
Trial completion date
2022-04-19, 1401/01/30
Scientific title
Investigating the effect of using autologous platelet factor in accelerating mastoidectomy repair with removal of the posterior wall and comparing it with the control group.
Public title
Investigating the effect of autologous platelet factor in ear repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Performing mastoidectomy by removing the posterior wall
Exclusion criteria:
Having anemia
Complications during surgery such as facial paralysis
Breastfeeding
Pregnancy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with ''www.randomization.com'' website will be done. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study subjects will be unaware of the intervention and control groups. In this study beacause placebo will be used in parallel with the drug, the participants will not know whether the drug or the placebo is being used.
Placebo
Used
Assignment
Parallel
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
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.605
Health conditions studied
1
Description of health condition studied
Mastoidectomy
ICD-10 code
H95.1
ICD-10 code description
Other disorders of ear and mastoid process following mastoidectomy
Primary outcomes
1
Description
The duration of epithelialization of the eardrum
Timepoint
At the beginning of the study (before the start of the intervention) and 14, 30 and 90 days after the use of autologous platelet factor
Method of measurement
Otoscopy with a microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, in addition to Gelfoam, from 4 to 8 cc of throat fibrin enriched with platelets (Iranian Blood Transfusion Organization, Mashhad, Iran) will be used which is placed in the middle ear area above and below.
Category
Treatment - Drugs
2
Description
Control group: In this group of patients, only 4 to 8 cc of Gelfoam (Blood Transfusion Organization of Iran, Mashhad, Iran) will be used which is placed in the area of the middle ear below and above.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Navid Noorizadeh
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3845 1521
Email
nourizadeh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayormbarhan
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3845 1521
Email
ramresearch@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
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
009838451521
Email
Nourizadehn@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
009838451521
Email
Nourizadehn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Navid Nourizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
009838451521
Email
Nourizadehn@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available