This is a double-blind, double-blind study that is conducted in Phase 3 trial Studies. It aims to prevent infection and improve wound healing incision cesarean section. The study population is pregnant women admitted to the hospital for cesarean delivery. Inclusion criteria study are pregnant women under 40 years of age and gestational age of more than 37 weeks, without previous underlying illness, have a classic cut (Pfannenstiel incision) of cesarean section during surgery. Patients randomly divided into three groups of 36 people. A total of 108 patients are selected. Assign interventions in each group in parallel. In the first group, patients receive cefazolin solution with normal saline, the second group only receives normal saline and the third group (the control group) does not receive the drug. Then patients are examined on the 5th and 10th days after surgery. The required information and the rate of infection and wound healing (based on REEDA criteria) are collected through by observation and checklist. Then it will be analyzed by statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092436376N1
Registration date:2017-10-23, 1396/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-23, 1396/08/01
Registrant information
Name
Elaheh Fahimi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3565 6134
Email address
fahimie89@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Sabzevar University of Medical Sciences
Expected recruitment start date
2017-09-27, 1396/07/05
Expected recruitment end date
2017-10-11, 1396/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of topical cefazolin solution versus normal saline in reducing cesarean section infection
Public title
Effect of topical cefazolin on reducing cesarean section infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women; Gestational age; Having a living and single fetus; Absence of underlying illness; Classic cesarean section (van Steele); Lack of rupture of the Amniotic sac
Exclusion criteria: Women under the age of 18 and over 40 years; Gestational age below 37 weeks; Stillbirth; History of underlying disease; Addiction; Recent antibiotic use; bleeding more than usual during cesarean section; non-classic cesarean sections; Rupture of the Amniotic sac longer than 18 hours
Age
From 17 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This is a double-blind trial. Patients accidentally block the block into 3 groups. Assign the groups to study in parallel.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Asad Abadi Street, Central Organization of abzevar University of Medical Sciences, Sabzevar
City
Sabzevar
Postal code
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.MEDSAB.REC.1396.37
Health conditions studied
1
Description of health condition studied
Infection Caesarean section
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
redness
Timepoint
Days 5 and 10
Method of measurement
Red spot on both sides of the wound
2
Description
Edama
Timepoint
Days 5 and 10
Method of measurement
Check swelling of the wound and measure to cm
3
Description
Ecchymosis
Timepoint
Days 5 and 10
Method of measurement
Check ecchymosis of the wound and measure to cm
4
Description
Discharge
Timepoint
Days 5 and 10
Method of measurement
observation
5
Description
approximation
Timepoint
Days 5 and 10
Method of measurement
observation
Secondary outcomes
1
Description
pain
Timepoint
Days 1, 5 and 10
Method of measurement
Measuring the severity of pain based on fatigue from 1 to 5
Intervention groups
1
Description
First group (intervention): Immediately after sewing the fascia, a venous Cefazolin 1000 mg vial with 300 ml of normal saline was washed.
Category
Treatment - Drugs
2
Description
Second group (intervention): Immediately after sewing the fascia with 300 cc normal saline was washed.
Category
Placebo
3
Description
Third group (control): No washing is done (routine method).