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Protocol summary
A Two arm, triple blind, randomized controlled trial on 34 patients
A Two arm, triple blind, randomized controlled trial on 46 patients
A Two arm, triple blind, randomized controlled trial on 3446 patients
کارآزمایی شاهددار تصادفی دوگروه و سه سویه کور بر روی 34 بیمار
کارآزمایی شاهددار تصادفی دوگروه و سه سویه کور بر روی 46 بیمار
کارآزمایی شاهددار تصادفی دوگروه و سه سویه کور بر روی 3446 بیمار
General information
34
46
3446
empty
The project manager's mistake in registering the sample size
The project manager's mistake in registering the sample size
empty
اشتباه مجری طرح در ثبت حجم نمونه
اشتباه مجری طرح در ثبت حجم نمونه
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Amin Dalili
Full name of responsible person - Persian: امین دلیلی
Street address - English: Ibn-e-Sina St.Imam Reza Hospital
Street address - Persian: خیابان ابن سینا -بیمارستان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 009851
Phone: +98 51 3851 5255
Fax:
Email: daliliam@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Amin Dalili
Full name of responsible person - Persian: امین دلیلی
Street address - English: Ibn-e-Sina St., Imam Reza Hospital
Street address - Persian: خیابان ابن سینا -بیمارستان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 009851
Phone: +98 51 3851 5255
Fax:
Email: Daliliam@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: Amin Dalili Full name of responsible person - Persian: امین دلیلی Street address - English: Ibn-e-Sina St.ImamSt., Imam Reza Hospital Street address - Persian: خیابان ابن سینا -بیمارستان امام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 009851 Phone: +98 51 3851 5255 Fax: Email: daliliamDaliliam@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: محسن تفقدی
Full name of responsible person - Persian: Mohsen Tafaghodi
Street address - English: Ghoreshi building .Daneshgah St
Street address - Persian: خیابان دانشگاه-جنب سینما هویزه -ساختمان قرشی-معاونت پژوهش و فناوری
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 009851
Phone: +98 51 3841 1538
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Ghoreshi building, Daneshgah St.
Street address - Persian: خیابان دانشگاه-جنب سینما هویزه -ساختمان قرشی-معاونت پژوهش و فناوری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 009851
Phone: +98 51 3841 1538
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: محسن تفقدیMohsen Tafaghodi Full name of responsible person - Persian: Mohsen Tafaghodiمحسن تفقدی Street address - English: Ghoreshi building ., Daneshgah St. Street address - Persian: خیابان دانشگاه-جنب سینما هویزه -ساختمان قرشی-معاونت پژوهش و فناوری City - English: mashhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 009851 Phone: +98 51 3841 1538 Fax: Email: vcresearch@mums.ac.ir Web page address:
Protocol summary
Study aim
Determination of the effectiveness of ozone olive oil in wound healing in patients with pilonidal abscess treated with extensive tissue resection surgery
Design
A Two arm, triple blind, randomized controlled trial on 46 patients
Settings and conduct
The patients, the surgeon, the nurse who records the data and data analyser are blinded to the allocated groups
Participants/Inclusion and exclusion criteria
Age over 15 years and with the diagnosis of abscess and
Pilonidal sinus undergoing surgical treatment with extensive tissue resection
Intervention groups
In patients with operated pilonidal sinus abscess, conventional dressing and dressing with ozone olive oil are performed and the wound healing process is compared between the two groups
Main outcome variables
The severity of pain, infection, bleeding and wound healing
General information
Reason for update
The project manager's mistake in registering the sample size
Acronym
IRCT registration information
IRCT registration number:IRCT20190423043356N3
Registration date:2022-01-26, 1400/11/06
Registration timing:prospective
Last update:2023-12-25, 1402/10/04
Update count:1
Registration date
2022-01-26, 1400/11/06
Registrant information
Name
Amin Dalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 2557
Email address
daliliam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of ozone olive oil in wound healing of patients with pilonidal sinus treated with extensive tissue resection surgery
Public title
Evaluation of the effectiveness of ozone olive oil in wound healing of patients with pilonidal sinus treated with extensive tissue resection surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the pilonidal sinus by the surgeon
Extensive removal of tissue
Age between 15-65
Exclusion criteria:
Age less than 15 years
Patient dissatisfaction
Past surgical history
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be individually randomized using block randomization method in quadruple blocks by randomization.com website, Allocation concealment will be done using sealed, opaque, and sequentially numbered envelopes
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researcher, Patients, The nurse who collects the data ,Data analyzer
Placebo
Used
Assignment
Parallel
Other design features
It is a diagnostic and therapeutic method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ibn-e-Sina St, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.484
Health conditions studied
1
Description of health condition studied
Pilonidal sinus
ICD-10 code
K60
ICD-10 code description
Pilonidal sinus
Primary outcomes
1
Description
The severity of pain
Timepoint
Daily visits and then every other day up to 10 days and then weekly until the wound heals
Method of measurement
Physical examination by the surgeon and VAS score
2
Description
The severity of the bleeding
Timepoint
Daily visits and then every other day up to 10 days and then weekly until the wound heals
Method of measurement
Physical examination by the surgeon
3
Description
Infection
Timepoint
Daily visits and then every other day up to 10 days and then weekly until the wound heals
Method of measurement
Physical examination by the surgeon
4
Description
Wound healing
Timepoint
Daily visits and then every other day up to 10 days and then weekly until the wound heals
Method of measurement
Physical examination by the surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: standard treatment and ozone olive oil ointment
Category
Treatment - Drugs
2
Description
Control group: Standard treatment (daily irrigation with Normal Saline serum and dressing)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Dalili
Street address
Ibn-e-Sina St., Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3851 5255
Email
Daliliam@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
Ghoreshi building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3841 1538
Email
vcresearch@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
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
Daliliam@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
Daliliam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
Daliliam@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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available