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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200919048755N1
Enrollment
100
Registered
2020-11-19
Start date
2020-02-19
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of the vaginal Scrub site in gynecological surgeries.

Interventions

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 c

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.;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 m

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Vaezi

Tabriz University of Medical Sciences

hfallah.tbz@gmail.com+98 41 3544 7593

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026