Surgical staples compared with subcuticular suture for skin closure after cesarean delivery.
Design: We conducted a single-center randomized controlled trial that included women with viable pregnancies (≥ 24 weeks) undergoing cesarean delivery at University Hospital, Motahary, Urmia, Iran from Aprill to November 2014. All cesarean types were included - scheduled or unscheduled and primary or repeat cesareans. Women were excluded for the following reasons: inability to obtain informed consent, immune compromising disease (e.g. AIDS), chronic steroid use, diabetic mellitus and BMI≥30. Of 266 women,133 were randomized to staples and 133 women to suture group and compared for wound complications, scar and time of skin closure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061322679N1
Registration date:2015-11-18, 1394/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Javad Zeinali
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 3118
Email address
zeinali_im@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical staples compared with subcuticular suture for skin closure after cesarean delivery. A Randomized Controlled Trial
Public title
Surgical staples compared with subcuticular suture for skin closure after cesarean delivery. A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult women with 18 years old and viable pregnancies (≥ 24 weeks), emergency or elective cesarean delivery, primary or repeat cesareans; exclusion criteria: inability to obtain informed consent; gestationa age<24weeks; pregnancy with dead fetus;
immune compromising disease (e.g. AIDS); chronic steroid use; sever malnutrition; prolong rupture of membrane; suprapubic scar; diabetic mellitus and BMI≥30; drug abuser; fetus macrosomia; heparin or warfarin therapy, coagulopathy.
Age
From 1 year old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
266
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients randomize with concealed envelop colors that choose by them in two groups.
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
2
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalate Avu - Urmia
City
Urmia
Postal code
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
irumsu.rec.1393.28
Health conditions studied
1
Description of health condition studied
cesarean wound complications, such as disruption or infection
ICD-10 code
y83-y84
ICD-10 code description
y83.8
2
Description of health condition studied
ICD-10 code
ICD-10 code description
3
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
WOUND SCALE
Timepoint
6 weeks later
Method of measurement
Vancouver Scar Scale
2
Description
Wound seperation
Timepoint
1 and 3 days after surgery
Method of measurement
Yes or No
3
Description
Seroma
Timepoint
1 and 3 days after surgery
Method of measurement
Yes or No
4
Description
Time of skin closure
Timepoint
At surgery
Method of measurement
minute
5
Description
Pain
Timepoint
1 and 3 days after surgery
Method of measurement
Score from 0 to 10
Secondary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Skin closure with subcuticular suture
Category
Prevention
2
Description
Skin closure with staples
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital of Urmia University of Medical Sciences
Full name of responsible person
Sahar Asadi
Street address
Motahari Hospital, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Urmia University of Medical Sciences - Dr Mohebi
Full name of responsible person
Dr Mohebi
Street address
Resalat ave
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Urmia University of Medical Sciences - Dr Mohebi
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
Urmia University of Medical Sciences
Full name of responsible person
Sahar Asadi
Position
Medical Doctor
Other areas of specialty/work
Street address
Motahari Hospital
City
Urmia
Postal code
Phone
+98 44 3348 3118
Fax
Email
saharasadi03@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Khomeini Hospital of Urmia University
Full name of responsible person
Javad Zeinali
Position
Subspecialist
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Urmia
City
urmia
Postal code
Phone
+98 443483118
Fax
Email
zeinali_im@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Javad Zeinali
Position
Subspecialist
Other areas of specialty/work
Street address
Emam Hospital
City
Urmia
Postal code
Phone
+98 44 3348 3118
Fax
Email
zeinali_im@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)