A randomized clinical trial of chlorhexzidine alcohol 4% compared with povidin Iodine 10% for vaginal scrub in gynecologic surgeries: complications and microbial flora
Comparison of the effects of 4% alcohol chlorhexidine and 10% iodine for vaginal lavage in gynecological surgeries: Complications and microbial flora
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 100 patients using random number table
Settings and conduct
Study will be done in Al zahra hospital of Tabriz. Sampling is done using convenience sampling method and the number of statistical samples of the study are 108 people who are equally divided into two control and experimental groups. first, using a table of random numbers, a sequence of letters of the web will be produced equal to the number of statistical samples and equally for the two experimental and control groups. Anti-septic solutions are marked with two English letters A&B and according to the sequence of letters created, they will be used in a double-blind manner depending on the type of intervention in the case and control groups, and the solution symbol used in the data collection sheet will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidates for elective vaginal surgery؛ Satisfaction to participate in the study؛ All patients aged 18 to 65 years with indication for vaginal surgery.
Exclusion criteria: Sensitivity to povidone iodine or chlorhexidine alcohol؛ Evidence of active infection at the site of surgery؛ Having systemic diseases predisposing to infections such as diabetes and immunodeficiency disease؛ Taking cytotoxic drugs and corticosteroids in the last 6 months؛ Existence of active wound or laceration at the operation site؛ BMI above 30؛ Patient discharge on the day of surgery.
Intervention groups
Comparison of the effects of chlorhexidine alcohol and Ipovidine iodine on vaginal lavage in gynecological vaginal surgeries
Main outcome variables
Strength, durability, side effects of chlorhexidine alcohol and Ipovidine iodine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048755N1
Registration date:2020-11-19, 1399/08/29
Registration timing:retrospective
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Hamed Fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3668 0583
Email address
hfallah.tbz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial of chlorhexzidine alcohol 4% compared with povidin Iodine 10% for vaginal scrub in gynecologic surgeries: complications and microbial flora
Public title
A randomized clinical trial of chlorhexzidine alcohol 4% compared with povidin Iodine 10% for vaginal scrub in gynecologic surgeries: complications and microbial flora
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Al-Zahra Hospital in Tabriz and candidates for elective vaginal surgery
Consent to participate in the study
Exclusion criteria:
Hypersensitivity to povidine iodine or chlorhexidine alcohol
Evidence of active infection at the site of surgery
Having systemic diseases predisposing to infections such as diabetes or immunodeficiency diseases such as HIV
Taking cytotoxic drugs and corticosteroids in the last 6 months
Existence of active wound or laceration at the operation site
BmI>30
Discharge of the patient on the day of surgery
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be as follows: first, using a table of random numbers, a sequence of letters A and B. The same number of statistical samples will be produced equally for the two experimental and control groups. Anti-diaphonic solutions are marked with two English letters A and B and according to the sequence of letters created, they will be used in two ways depending on the type of intervention (solution) in both case and control groups and the solution symbol used on the data sheet collection will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The sampling method will be as follows: first, using a table of random numbers, a sequence of numbers;The same number of statistical samples will be produced equally for the two experimental and control groups. Anti-septic solutions are marked with two English letters A and B and according to the sequence of letters created, they will be used in two ways depending on the type of intervention (solution) in both case and control groups and the solution symbol used on the sheet. Data collection will be recorded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Sciences
Street address
Number29,6th dahmetri,mollasadra Blvd,Daneshgah Alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.TBZMED.REC.1398.1229
Health conditions studied
1
Description of health condition studied
Infection of the vaginal Scrub site in gynecological surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
povidine iodine disinfectant power
Timepoint
Before and immediately after the scrub (in the first minute)
Method of measurement
The method will be that in both groups of patients, before scrub and immediately after it (in the first minute) microbial culture using a sterile swab and transfering it to a transport environment, based on the type and count of microorganisms will be done. The extent of vaginal microbial load reduction after the use of chlorhexidine 4% and betadine 10% solution will be determined and the data will be analyzed.
2
Description
Durability of chlorhexidine alcohol effect
Timepoint
Before and immediately after the scrub (in the first minute)
Method of measurement
To compare the shelf life of the disinfectant solution or its inactivation during bleeding at the end of surgery (in the first minute after surgery), re-sampling for culture (in the first minute) using a sterile swab and transferring it to a transport medium, will be done .
3
Description
Durability of povidone iodine effect
Timepoint
Before and immediately after the scrub (in the first minute)
Method of measurement
To compare the shelf life of the disinfectant solution or its inactivation during bleeding at the end of surgery (in the first minute after surgery), re-sampling for culture (in the first minute) using a sterile swab and transferring it to a transport medium, will be done.
4
Description
Side effects of Povidine-iodine
Timepoint
Immediately after using the solution and at the end of the operation and in the morning after the operation
Method of measurement
Observation and examination of the vulva and vagina in terms of local complications occurred in the mentioned solution based on the severity of the complication (burning, erythema, swelling and inflammation, scaling, scarring, etc.) based on the design questionnaire,immediately after using The solution ,at the end of the operation and in the morning after the operation. redness and burning at the site is considered mild complication, moderate complication is in case of scaling, and severe complication is in case of ulceration.
5
Description
Side effects of chlorhexidine alcohol
Timepoint
Immediately after using the solution and at the end of the operation and in the morning after the operation
Method of measurement
Observation and examination of the vulva and vagina in terms of local complications occurred in the mentioned solution based on the severity of the complication (burning, erythema, swelling and inflammation, scaling, scarring, etc.) based on the design questionnaire,immediately after using The solution ,at the end of the operation and in the morning after the operation. redness and burning at the site is considered mild complication, moderate complication is in case of scaling, and severe complication is in case of ulceration.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Chlorhexidine alcohol will contain 4% alcohol. Due to the fact that this antiseptic solution does not exist in our country, it will be prepared and delivered by a clinical pharmacist with the mentioned percentage in the Faculty of Pharmacology of Tabriz University of Medical Sciences. In each patient in three stages, before the operation, immediately after the operation (in the first minute) and then at the end of the operation,scrub with antiseptic solution using a sterile swab will be done, sampling of the vaginal walls and fornixes is prepared and transferred to the transport environment and Will be sent for microbial culture by one of the laboratory personnel.The operation site will be examined for local complications such as burning, inflammation, redness, scaling, and ulceration:immediately after the use of antiseptic, at the end of the operation, and in the morning after the operation by a trained nurse and will be recorded in the data sheet.
Category
Treatment - Surgery
2
Description
Control group: Povidine iodine 10%.In each patient in three stages, before the operation, immediately after the operation (in the first minute) and then at the end of the operation,scrub with antiseptic solution using a sterile swab will be done, sampling of the vaginal walls and fornixes is prepared and transferred to the transport environment and Will be sent for microbial culture by one of the laboratory personnel.The operation site will be examined for local complications such as burning, inflammation, redness, scaling, and ulceration:immediately after the use of antiseptic, at the end of the operation, and in the morning after the operation by a trained nurse and will be recorded in the data sheet.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Maryam Vaezi
Street address
No.29,6th Dah metri,Mollasadra Blvd,Daneshgah alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Phone
+98 41 3668 0583
Email
Hfallah.tbz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Vaezi
Street address
Number29,6th Dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Phone
+98 41 3544 7593
Email
hfallah.tbz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Vaezi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Number29,6th Dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Phone
+98 41 3544 7593
Email
hfallah.tbz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Vaezi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Number29,6th dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Phone
+98 41 3544 7593
Email
hfallah.tbz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Vaezi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Number29,6th Dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5165943333
Phone
+98 41 3544 7593
Email
hfallah.tbz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available