Comparing the effect of intraoperative cesarean wound lavage with gentamicin solution in wound infection with normal saline- A double blind randomized controlled clinical trial
From Agust 2014 to Agust 2015 , a randomized double-blinding clinical trial is conducted at two educational hospitals of Ahvaz Jundishapur University of Medical Sciences (Imam Khomeini hospital and Razi Hospital). A total of 360 eligible participants will be enrolled in the study. Inclusion criteria were cesarean section surgery less than 40 minutes and Pfannenstiel incision. Patients were excluded if they have with extreme obesity (>100 kg), Immunodeficiency, blood hypertension and diabetes mellitus. Participants will be randomly allocated into two study groups including control group and intervention group. The wounds of alternate patients were irrigated during surgery either with normal saline (300 cc) or with gentamicin solution (80 mg) plus normal saline (300 cc). Both groups will be followed during 30 days after surgery. Then they will be assessed for signs and symptoms of surgical-site infection as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021221048N1
Registration date:2015-04-11, 1394/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-11, 1394/01/22
Registrant information
Name
ُSoghra Ariazanganeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6504
Email address
ariazanganeh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of intraoperative cesarean wound lavage with gentamicin solution in wound infection with normal saline- A double blind randomized controlled clinical trial
Public title
Effect of Gentamicin and normal salin on post-cesarean infection
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Cesarian section surgery less than 40 minutes, Pfannenstiel incision
exclusion criteria: Obesity (>100 kg), Immunodeficiency diseases , hypertension and diabetes mellitus
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
360
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
in this study 0.9% Sodium Chloride Injection, Iran Pharmaceutical and Parenteral Co. and Gentamicin from Sobhan Rasht Co. will be used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan blvd, central building Of AJUMS
City
Ahvaz
Postal code
Approval date
2015-02-02, 1393/11/13
Ethics committee reference number
AJUMS.REC.1393.315
Health conditions studied
1
Description of health condition studied
Post cesarian section subcutaneous infection
ICD-10 code
O86.0
ICD-10 code description
Infected: caesarean section wound perineal repair following delivery
Primary outcomes
1
Description
infection
Timepoint
30 days after cesarian section
Method of measurement
Redness, tenderness in the wound or wound dehiscence
2
Description
readmission
Timepoint
30 days after cesarian section
Method of measurement
more than 1 day readmission due to post cesarian section infection
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The wounds of patients were irrigated with the 300 cc normal saline before closing the wound.
Category
Prevention
2
Description
Intervention group: The wounds of patients were irrigated with 300cc normal saline plus 80 mg gentamicin before closing the wound.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Ahvaz
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Razieh Mohammad Jafari
Street address
Fertility Infertility and Perinatology Research Center. Ahvaz Jundishapur University of Medical Sciences.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Fertility Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Scie