Hypospadias is one of most common genitalia abnormality in childhood.The goal of hypospadias repair is reconstruction of the penis directly with a meatus in the natural area and appropriate urine flow with normal shape and creating self confidence in a child.Fistula,stenosis,inaccessibility to a favorable condition due to the beauty and failure of treatment that requires re-operation is a major complication of surgical repair.One of the goals of achieving a beautiful appearance after surgery is to find a method to reduce the scar after the hypospadias repair.One of the most effective nonsurgical methods of scar treatment,based on scientific evidence,is using of silicone gel.Therefore,we decided to conduct a double-blind randomized trial,Which patients and researcher measure the outcome of the study are unaware of the type of intervention,that investigate the effect of silicone gel on scar reduction after hypospadias repair.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080735551N1
Registration date:2017-08-21, 1396/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Iman Shamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3232 6645
Email address
shamohammadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of silicone gel application for reduction of scars after repair of hypospadias
Public title
Efficacy of silicone gel application for reduction of scars after surgical wound healing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:Patients undergoing hypospadias repair and referring to the clinic of Namazi Hospital after the surgery after obtaining informed consent.
Exclusion: Patients who have an open wound or open wound infection or history of any allergy or skin disease, or the inability to follow the patient and complete the course of treatment.
Age
From 6 months old to 7 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method The study design uses a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Shiraz Medical School
Street address
Shiraz, Zand Avenue, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
7134814336
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.53
Health conditions studied
1
Description of health condition studied
Keloid scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Height of scar
Timepoint
Before intervention and six months after the end of intervention
Method of measurement
With a ruler and scoring based on the Vancouver scar scale
2
Description
Vascularity of scar
Timepoint
Before intervention and six months after the end of intervention
Method of measurement
Observation and evaluation of post-white fill velocity due to pressure and scoring based on the Vancouver scar scale
3
Description
Pliability of scar
Timepoint
Before intervention and six months after the end of intervention
Method of measurement
Touch and scoring based on the Vancouver scar scale
4
Description
Pigmentation of scar
Timepoint
Before intervention and six months after the end of intervention
Method of measurement
view and scoring based on the Vancouver scar scale
Secondary outcomes
1
Description
Skin atrophy
Timepoint
Six months after the end of intervention
Method of measurement
Has or has not
Intervention groups
1
Description
Intervention group: Administration of silicone gel ointment on a lesion twice a day for two months
Category
Treatment - Drugs
2
Description
Control group: Administration of Vaseline ointment on a lesion twice a day for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi Hospital
Full name of responsible person
Dr. Iman Shamohammadi
Street address
Shiraz, Zand Square, Namazi Hospital, Department of Urology
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Assistance of Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seyed Bassir Hashemi
Street address
Shiraz-Zand Avenue- Central Building of Shiraz University of Medical Sciences - 7th floor, Office of Assistance of Research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistance of Research of Shiraz University of Medical Sciences
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
Shiraz university of medical sciences
Full name of responsible person
Dr. Iman Shamohammadi
Position
Resident of Urology
Other areas of specialty/work
Street address
Shiraz-Namazi Hospital-Department of Urology
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
imanshamohammadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Mehdi Shirazi
Position
Surgeon and specialist of urology
Other areas of specialty/work
Street address
Shiraz-Namazi Hospital-Department of Urology
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
shirazim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Iman Shamohammadi
Position
Resident of urology
Other areas of specialty/work
Street address
Shiraz-Namazi Hospital-Department of Urology
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
imanshamohammadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)