Comparison of complications between open surgical procedure and Z- plasty in pilonidal sinus surgery
Design
A total of 50 patients, 15 to 40 years old, with Pilonidal sinus, who will refer to the hospital, will be randomly selected and divided into two groups using the Balanced Block Randomization method.
Settings and conduct
After obtaining the necessary permissions from Birjand University of Medical Sciences, 50 patients from the pilonidal sinus that are referred to Imam Reza Hospital will be available in accessible form.
Participants/Inclusion and exclusion criteria
Incusion criteria:Patients with pylonidal sinus; 20-50 years old.
Exclusion criteria: systemic disorders such as diabetes mellitus or other diseases affecting wound healing; Inflammation, infection, discharge ؛ history of corticosteroid use; chemotherapy and other drugs that disrupt the wound healing process; BMI>30؛ The extent of the ulcer more than 10% of the pilonidal standard size (18 cm2)
Intervention groups
Patients with pilonidal sinus: one group will be treated by open-ended method and the other group by Z-plasty.
Main outcome variables
Recurrence
Wound infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111211008375N16
Registration date:2018-06-01, 1397/03/11
Registration timing:registered_while_recruiting
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the complication of Z-plasty repair vs secondary healing in pilonidal sinus.
Public title
Comparison between the complication of Z-plasty repair Vs Secondary healing in pilonidal sinus.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pilonidal sinus
Exclusion criteria:
General disorders, such as diabetes mellitus, or other diseases affecting wound healing ؛ Inflamation, infection,discharge ؛ History of corticosteroid use, chemotherapy and other drugs that disrupt the wound healing process;The extent of each wound is more than 10% of the pylonidal standard size; BMI>30
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Block Randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Birjand University of Medical Sciencee
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
Ir.bums.REC.1395.265
Health conditions studied
1
Description of health condition studied
Pilonidal sinus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Recurrence
Timepoint
Second and third week and third and sixth months after surgery
Method of measurement
Examination by surgeon
2
Description
Wound infection
Timepoint
Second and third week and third and sixth months after surgery
Method of measurement
Examination by surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Primary repair by Z-plasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Seyyed AmirKazem Vejdan
Street address
Taleghani St
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemy
Street address
Ghaffari St , Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Birjand University of Medical sciences
Position
General surgeon, Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza hospital
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
Specialist in general surgery, Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani St
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toktam Shadi- Sajede Afroozi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ghaffari St.Birjand University of Medical sciences
City
Birjand
Province
South Khorasan
Postal code
9715711396
Phone
+98 56 3243 3872
Email
Eholadi17@yahoo.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
It is a single blinded and the patients' confidentiality concerned
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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