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IRCT20200919048755N1 IRCT 2020-11-19 Tabriz University of Medical Sciences A randomized clinical trial of chlorhexzidine alcohol 4% compared with povidin Iodine 10% for vaginal scrub in gynecologic surgeries: complications and microbial flora A randomized clinical trial of chlorhexzidine alcohol 4% compared with povidin Iodine 10% for vaginal scrub in gynecologic surgeries: complications and microbial flora 2020-02-19 anticipated 100 Complete https://irct.ir/trial/51028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Infection of the vaginal Scrub site in gynecological surgeries. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Maryam Vaezi
Number29,6th Dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
Tabriz Iran (Islamic Republic of) 5165943333 +98 41 3544 7593 hfallah.tbz@gmail.com Tabriz University of Medical Sciences scientific Maryam Vaezi
Number29,6th dahmetri,Mollasadra Blvd,Daneshgah Alley,Tabriz city
Tabriz Iran (Islamic Republic of) 5165943333 +98 41 3544 7593 hfallah.tbz@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients referred to Al-Zahra Hospital in Tabriz and candidates for elective vaginal surgery Consent to participate in the study 18 years 65 years Female 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 Treatment - Surgery Treatment - Surgery 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. 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. 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. 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 . 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. 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. 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. Tabriz University of Medical Sciences Approved 2020-02-17 Ethics committe of Tabriz University of Medical Sciences Number29,6th dahmetri,mollasadra Blvd,Daneshgah Alley,Tabriz city Tabriz East Azarbaijan Iran (Islamic Republic of)