comparative study of the outcomes of suture technique with suture fluid adhesion and routine cesarean section
Design
This study is a non-blinded clinical trial. The study population will be included all women referred to the gynecology ward of Imam Reza hospital Kermanshah Hospital.32 eligible patients will be selected conveniently and randomly will be assigned into two intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is a non-blinded one. After the intervention, both groups will be compared in terms of pain severity and the rate of wound infection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; gestational age greater than or equal to 24 weeks; termination of pregnancy with an elective or emergency cesarean section.
Exclusion criteria: BMI> 30; pregnancy with dead fetus; drug abuse; fetal macrosomia; prolonged runoff and coagulopathy
Intervention groups
In the intervention group after the cesarean section, EPIGLU suture adhesive that made in Germany will be used. In the control group, sutures are used as usual.
Main outcome variables
Intensity of pain, Wound infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N134
Registration date:2019-12-26, 1398/10/05
Registration timing:prospective
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcomes of suture technique with suture fluid adhesion and routine cesarean section
Public title
Comparison of the outcomes of suture technique with suture fluid adhesion and routine cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
gestational age greater than or equal to 24 weeks
termination of pregnancy with an elective or emergency cesarean section
Exclusion criteria:
BMI> 30
pregnancy with dead fetus
drug abuse
fetal macrosomia
prolonged runoff and coagulopathy
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly by a coin toss
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.KUMS.REC.1398.110
Health conditions studied
1
Description of health condition studied
cesarean
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
Intensity of pain
Timepoint
End of study
Method of measurement
Asking the patient
2
Description
Wound infection
Timepoint
End of study
Method of measurement
Doctor observation
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group after the cesarean section, EPIGLU suture adhesive that made in Germany will be used.
Category
Treatment - Devices
2
Description
In the control group, sutures are used as usual.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Hoda Alsharif
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
hodaalsharif@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hoda Alsharif
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
hodaalsharif@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mzangeneh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hoda Alsharif
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
hodaalsharif@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail