The effect of using gentamicin in subcutaneous tissue, before skin suturing at cesarean section infection
Design
A randomized clinical trial, with parallel groups, phase 3، without blindness that, 242 patients randomly divided into two groups of 121 subjects with block sizes of 4 and 6.
Settings and conduct
Patients referred to Babol hospitals (Rouhani and Shahid Yahyanezhad) and Imam Sari hospitals for cesarean section, randomly divided into two Intervention groups with block sizes of 4 and. Then they were assessed for signs and symptoms of surgical-site infection as the primary outcome.
Participants/Inclusion and exclusion criteria
Inclusion criteria: cesarean section surgery less than 40 minutes and Pfannenstiel incision.
Exclusion Criteria: extreme obesity (>100 kg), Immunodeficiency, hypertension and diabetes mellitus.
Intervention groups
Intervention group: The wounds of patients were irrigated with 300cc normal saline plus 80 mg gentamicin before closing the wound.
Control group: The wounds of patients were irrigated with the 300 cc normal saline before closing the wound.
Main outcome variables
infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046261N1
Registration date:2020-05-14, 1399/02/25
Registration timing:retrospective
Last update:2020-05-14, 1399/02/25
Update count:2
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
معصومه Masoomeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 7230
Email address
zakeri.m@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1733-01-20, 1111/11/01
Expected recruitment end date
1743-03-21, 1122/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using Gentamicin in subcutaneous tissue, before skin suturing at cesarean section infection
Public title
The effect of Gentamicin at cesarean section infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
cesarean section surgery less than 40 minutes
Pfannenstiel incision
Exclusion criteria:
Women with extreme obesity (>100 kg)
Immunodeficiency
Diabetes mellitus
Hypertension
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
242
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups of 121 subjects with four and six blocks and an allocation ratio of 1:1. Participants allocation sequence in two groups performed with a Randomizer software. Opaque sealed sequentially numbered envelops used for allocation concealment
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 Mazandaran University Of Medical Sciences
Street address
Vice –Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MAZUMS.REC.1399.148
Health conditions studied
1
Description of health condition studied
Wound infection
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
wound infection
Timepoint
third and tenth day of the operation
Method of measurement
physical examination
2
Description
wound dehiscence
Timepoint
third and tenth day of the operation
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The wounds of patients were irrigated with 300cc normal saline plus 80 mg gentamicin (Exir Pharmaceutical Company) before closing the wound
Category
Prevention
2
Description
Control group: The wounds of patients were irrigated with the 300 cc normal saline before closing the wound.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Ebrahim Nasirifar
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8303
Email
enasiri@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Aliakbar Hedaiatizadeh
Street address
Vice Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square, Moalem Street. sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3325 7230
Email
akbar_hedayati@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim nasirifar
Position
Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditonal and complementary research center of Mazandaran University of Medical Scienses
City
Sari
Province
Mazandaran
Postal code
4847116548
Phone
+98 11 3354 3239
Email
enasiri@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasirifar
Position
Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditonal and complementary research center of Mazandaran University of Medical Scienses
City
Sari
Province
Mazandaran
Postal code
4847116548
Phone
+98 11 3354 3239
Email
enasiri@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim nasirifar
Position
Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditonal and complementary research center of Mazandaran University of Medical Scienses
City
Sari
Province
Mazandaran
Postal code
4847116548
Phone
+98 11 3354 3239
Email
enasiri@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD