Evaluation of the effect of metronidazole vaginal gel in reducing surgical site infection in patients undergoing elective hysterectomy
Design
Clinical trial without control group with parallel, randomized, phase 3 groups on 70 patients A random number table was used for randomization
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients are randomly divided into two groups. The first group is treated with metronidazole vaginal cream before surgery and the second group is treated with lubricant vaginal cream. The rate of infection at the surgical site is measured in 2 groups and 6 weeks after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for elective hysterectomy surgery, obtaining written consent
Exclusion criteria: hysterectomy after cesarean section, hysterectomy after normal delivery, emergency hysterectomies, patients who received broad-spectrum antibiotics before surgery, patient dissatisfaction, patient with vaginitis with cervicitis in the preoperative period
Intervention groups
Intervention group: Patients in this group will be treated with metronidazole vaginal cream daily for three nights before surgery. Then the patients will be operated on and 2 weeks and 6 weeks later, they will be examined for infection at the surgical site.
Control group: Patients in this group will be treated daily with lubricant vaginal cream from three nights before surgery. Then the patients will be operated on and 2 weeks and 6 weeks later, they will be examined for infection at the surgical site.
Main outcome variables
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N9
Registration date:2021-01-15, 1399/10/26
Registration timing:prospective
Last update:2021-01-15, 1399/10/26
Update count:0
Registration date
2021-01-15, 1399/10/26
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-28, 1399/11/09
Expected recruitment end date
2021-03-30, 1400/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of metronidazole vaginal gel in reducing surgical site infection in patients undergoing elective hysterectomy
Public title
Metronidazole vaginal gel and surgical site infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective hysterectomy
Obtaining written consent
Exclusion criteria:
Hysterectomy followed by cesarean section
Hysterectomy following a normal delivery
Emergency hysterectomies
Patients who have received broad-spectrum antibiotics before surgery
Patient dissatisfaction
Infection of the patient with vaginitis with cervicitis in the preoperative period
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2020-01-03, 1398/10/13
Ethics committee reference number
IR.MUI.MED.REC.1398.498
Health conditions studied
1
Description of health condition studied
Surgical site infection
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
Infection
Timepoint
Two weeks and six weeks after surgery
Method of measurement
Examination and patient history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will be treated with metronidazole vaginal cream daily for three nights before surgery. Then the patients will be operated on and 2 weeks and 6 weeks later, they will be examined for infection at the surgical site.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will be treated daily with lubricant vaginal cream from three nights before surgery. Then the patients will be operated on and 2 weeks and 6 weeks later, they will be examined for infection at the surgical site.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Fahime Sabet
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
Dr.fsabet@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fahime Sabet
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
Dr.fsabet@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahime Sabet
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
Dr.fsabet@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahime Sabet
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
Dr.fsabet@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.