According to high prevalence of pilonidal sinus and its painful nature which leads to significant morbidity, the pilonidal disease leads to long-lasting disturbance of daily activity. In the view of there is not yet any preferred method (open or closed) in the treatment of pilonidal disease, this study was conducted to compare these two methods. This study is a randomized clinical trial and all patients will be admitted with a diagnosis of pilonidal sinus disease and an informed consent will be taken. Patients randomly assign to either primary closure or secondary healing group. Total sample size was calculated 37cases for each groups of study. In primary repair group, the sinuses, tract and cyst will be removed with a healthy tissue margin of 2-3 mm and the defect will be replaced with a flap method and repaired with nylon string. In addition, a drain will be placed under the flap and will be removed within 24 to 48 hours. In secondary healing group (open group) involved tissues in pilonidal sinus site will be respected and tissue defect will be managed by continuous washing up to closure of wound by secondary healing. In both groups patients will be visited repeatedly the day after surgery, one week, one month and 6 month after surgery and will be evaluated for length of hospital stay, days to work, complete healing time, wound infection and recurrence of disease. All data will be recorded and statistically analyzed. In all cases, P value less or equal to the 0.05 will be considered statistically significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031312801N1
Registration date:2013-07-17, 1392/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-17, 1392/04/26
Registrant information
Name
Hamid Reza Makarchian
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0078
Email address
hr.makarchian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan Univesity of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Healing by primary closure versus open healing after surgery for pilonidal sinus
Public title
Healing by primary closure versus open healing after surgery for pilonidal sinus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients referred to general surgery clinic with pidonidal disease.
Exclusion criteria: chronic underlying disease; active infection at pilonial sinus site; patients with pilonidal abcess which were candidate to urgent drainage.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan Univesity of medical sciece
Street address
Hamedan, Hamedan University of Medical Science, Medicine university.
City
Hamedan
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
16/35/9/3492/پ/د
Health conditions studied
1
Description of health condition studied
pilonidal disease
ICD-10 code
L05.9
ICD-10 code description
Pilonidal cyst without abscess
Primary outcomes
1
Description
infection of wound site
Timepoint
1st day, 1st week, 1st month, 6th month.
Method of measurement
physical examination and history
2
Description
recurrance of disease
Timepoint
1st month, 6th month.
Method of measurement
physical examination
3
Description
time of complete healing of wound
Timepoint
1st week, 1st month, 6th month
Method of measurement
physical examination and history
4
Description
day to work
Timepoint
1st day. 1st week, 1st month, 6th month.
Method of measurement
history
Secondary outcomes
1
Description
length of stay at hospital
Timepoint
at time of admission and discharge
Method of measurement
following of admission
Intervention groups
1
Description
Surgery methods in control group: excision of affected tissue and secondary healing.
Category
Treatment - Surgery
2
Description
Surgery method in intervension group: excision of affected tissue and repair of wound with flap method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Makarchian
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Science research deputy
Full name of responsible person
Dr. Mohamad Hazavei
Street address
Hamedan University of Medical Science, Shahid Fahmide st.
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Science research deputy
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
Name of organization / entity
Hamedan University of Medical science
Full name of responsible person
Hamid Reza Makarchian
Position
general surgery resident
Other areas of specialty/work
Street address
Hamedan, Resaalat St. Beasat hospital of Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
makarchiyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of medical science
Full name of responsible person
Hamid Reza Makarchian
Position
general surgery resident
Other areas of specialty/work
Street address
Hamedan, Resaalat St. Beasat hospital of Hamedan.
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
makarchiyan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Nazila Hsanzadeh Ghavifekr
Position
general surgery resident
Other areas of specialty/work
Street address
Hamedan, Resaalat St. Beasat hospital of Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0050
Fax
Email
nazila.hasanzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)