1) Introduction: According To Recent Scientific Advances Hypertrophic Scar Is Still One Of The Major Medical Problems And Prevention Is The Best Strategy To Address This Problem. Scars Can Have A Negative Effect On Quality Of Life And A Source Of Confusion Is Due To The Decline In Confidence. Very Few Treatment Options For Bhyvd Oscar Suggested That Including Radiotherapy, Cryotherapy And Local Injection Of Corticosteroid Which Has A High Relapse Rate Associated With.
According To Recent Scientific Advances Hypertrophic Scar Is Still One Of The Major Medical Problems And Prevention Is The Best Strategy To Address This Problem. Therapeutic Use Of Low Level Laser Therapy (Low Level Laser Therapy) Or LLLT As A Safe Method Has Been Approved By The FDA.
On The Basis Of This Study Was To Determine The Effect Of Low Level Laser Therapy On Scar Formation Caused By Caesarean Pay.
2) General Objectives: To Determine The Effect Of Low Level Laser Therapy On Scar Formation Caused By Caesarean Section
3) Study Population And Data Collection Methods:
62 Women Who Underwent Elective Cesarean Section In Amir Hospital In Semnan Obstetric Reasons Are, Continues.
4) How To Use The Results:
The Results Of This Study Could Form The Effect Of Low Level Laser Therapy In The Prevention Of Hypertrophic Scars To Prove And Thus At High Risk Mothers Who Have Caesarean Scar Wounds Can Benefit From The Treatment Was.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011926099N1
Registration date:2016-02-07, 1394/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Elham Saffarieh
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
drsaffarieh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-01-06, 1394/10/16
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relationship low level laser therapy on scar formation caused by Caesarean section.
Public title
Effect of low level laser therapy on scar formation after cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Age 17 To 34; Gestational Age Between 37 To 42 Weeks; No History Of Previous Cesarean; The Absence Of Any Obstetric Complications; Lack Of Diseases That Can Delay Wound Healing; No Drugs Affecting Wound Healing And Scar; No Previous Suprapubic Scar; The Lack Of A History Of Keloid; No Smoking Or Drugs.
Exclusion Criteria: Duration Of Surgery> 90 Min; Any Complication Of Cesarean Section; Length Of Stay> 7 Days In The Hospital; Lack Of Consent For Continued Participation
Age
From 17 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences
City
semnan
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.SEMUMS.REC.1394.143
Health conditions studied
1
Description of health condition studied
Relationship low level laser therapy on scar formation caused by Caesarean section.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Incision Site
Timepoint
In The Experimental Group For 6 Days (24 Hours, 3, 5, 7, 9 And 11 Days After Cesarean Section)
Method of measurement
Mustang 2000 Machine Made In Russia, To Continuously Irradiated With Gaalas Diode Laser With A Wavelength Of 830 Nm (Infrared) At A Rate Of 4 Joules Per Square Centimeter And 620 Nm Wavelength (Red) By 4 Mj Cm Are Square. Angle Probe On The Skin Of 90 Degrees. In The Intervention Group And Control Group In The Same Conditions Laser Probe Placed On The Skin But No Laser Is Emitted. Since The Effect Of Low Level Laser On And Increase Mitochondrial Atp And Its Regenerative Effects Remain 24 To 72 Hours So We Distance Between The Laser Radiation Chose The Other Day. Resident Women In The Intervention Group Performed By Laser Irradiation And Safety Issues Are Fully Respected.
Secondary outcomes
1
Description
Oscar Thickness
Timepoint
6 Months
Method of measurement
Oscar the Surgical Site With the Vancouver Scar Sale Criterion Will be Assessed and Pain, Itching and Feeling Sick to the Scar Created by Visual Analog Scale Criteria is Evaluated. Photos of AutoCAD software in 2014 (AUTOCAD 2014) entered the area of the wound in the images and the thickness of the scar created in the image measured 6 months later. Oscar Thickness at Three Points in the Middle and a Centimeter of Wound Margin is Calculated by the Software.
Intervention groups
1
Description
Before The Intervention The Incision Site Both Groups Of Patients By 8-Megapixel Camera Iphone S6, Vertically And At A Distance Of 15 Cm Photographed. In The Experimental Group For 6 Days (24 Hours, 3, 5, 7, 9 And 11 Days After Cesarean Section) With The Mustang 2000 Is Made In Russia, To Continuously Irradiated With Gaalas Diode Laser With A Wavelength Of 830 Nm (Infrared) At A Rate Of 4 Joules Per Square Centimeter And 620 Nm Wavelength (Red) By 4 Joules Per Square Centimeter Are. 90 Degrees Angle Of The Probe On The Skin
Category
Treatment - Surgery
2
Description
Before The Intervention The Incision Site Both Groups Of Patients By 8-Megapixel Camera Iphone S6, Vertically And At A Distance Of 15 Cm Photographed. In The Intervention Group And Control Group In The Same Conditions Laser Probe Placed On The Skin But No Laser Is Emitted. Since The Effect Of Low Level Laser On And Increase Mitochondrial ATP And Its Regenerative Effects Remain 24 To 72 Hours So We Distance Between The Laser Radiation Chose The Other Day. Resident Women In The Intervention Group Performed By Laser Irradiation And Safety Issues Are Fully Respected.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital AmirAl-Momenin Semnan
Full name of responsible person
Dr Elham Saffarieh
Street address
Hospital AmirAl-Momenin Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Elham Saffarieh
Street address
Hospital AmirAl-Momenin Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Elham Saffarieh
Position
obstetricia et gynecologica
Other areas of specialty/work
Street address
Hospital AmirAl-Momenin Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
eli_saffarieh@yahoo.com;drsaffarieh@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Elham Saffarieh
Position
Obstetricia et Gynecologica
Other areas of specialty/work
Street address
Hospital AmirAl-Momenin Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
eli_saffarieh@yahoo.com;drsaffarieh@semums.ac.ir.
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Elham Saffarieh
Position
Obstetricia et Gynecologica
Other areas of specialty/work
Street address
Hospital AmirAl-Momenin Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
eli_saffarieh@yahoo.com;drsaffarieh@semums.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)