Protocol summary
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Study aim
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The effect of using gentamicin in subcutaneous tissue, before skin suturing at cesarean section infection
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Design
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A randomized clinical trial, with parallel groups, phase 3، double blind that 120 patients randomly divided into two groups of 60 subjects with block sizes of 4 and 6.
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Settings and conduct
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Patients referred to Imam Sari hospitals for cesarean section, randomly divided into two groups with block sizes of 4 and. Then they were assessed for signs and symptoms of surgical-site infection as the primary outcome.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18 to 40 years, gestational age of early term (37 to 38 weeks and 6 days) and full term (39 to 40 weeks and 6 days), elective admission, having a live fetus and mental health of the mother, Pfannenstiel incision.
Exclusion Criteria: Patients with known infections before surgery, underlying disorders such as diabetes and blood pressure, immune system deficiency diseases, history of taking drugs that weaken or strengthen the immune system, various cancers, coagulation disorders, malnutrition, and smoking and drug use and people with surgical wound infection in previous cesarean section.
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Intervention groups
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Intervention group: The wounds of patients were irrigated with 100cc normal saline plus 80 mg gentamicin before closing the wound.
Control group: The wounds of patients were irrigated with the 100 cc normal saline before closing the wound.
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Main outcome variables
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infection
General information
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Reason for update
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Due to the spread of covid-19 and the reduction of elective surgeries, therefore; The researcher decided to announce the change in the sample size and update the recorded information in this scientific database.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200126046261N1
Registration date:
2020-05-14, 1399/02/25
Registration timing:
prospective
Last update:
2023-07-13, 1402/04/22
Update count:
2
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Registration date
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2020-05-14, 1399/02/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2021-08-23, 1400/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of using Gentamicin in subcutaneous tissue, before skin suturing at cesarean section infection
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Public title
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The effect of Gentamicin at cesarean section infection
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Gestational age of early and full term
Elective admission
Having a live fetus
Mother's mental health
Pfannenstiel incision
Exclusion criteria:
Patients with known infection before surgery
Having underlying diseases (diabetes, blood pressure, types of cancers)
Patients with immune system deficiency
Coagulation disorders
Malnutrition
Smoking and drug use
People with a history of surgical wound infection in a previous cesarean section
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly divided into two groups of 60 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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participating patients and the surgeon did not know about receiving subcutaneous gentamicin.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-29, 1399/02/10
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Ethics committee reference number
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IR.MAZUMS.REC.1399.148
Health conditions studied
1
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Description of health condition studied
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Wound infection
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ICD-10 code
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O86.0
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ICD-10 code description
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Infection of obstetric surgical wound
Primary outcomes
1
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Description
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wound infection
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Timepoint
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The first day after surgery and the tenth and thirtieth day
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Method of measurement
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physical examination
2
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Description
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wound dehiscence
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Timepoint
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The first day after surgery and the tenth and thirtieth day
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Method of measurement
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physical examination
Secondary outcomes
1
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Description
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Pain in the operation area
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Timepoint
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The first day after surgery, the tenth day and the thirtieth day
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group: The wounds of patients were irrigated with 100 cc normal saline plus 80 mg gentamicin (Exir Pharmaceutical Company) before closing the wound
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Category
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Prevention
2
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Description
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Control group: The wounds of patients were irrigated with the 100 cc normal saline before closing the wound.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is still no plan for its puplish.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available