Preoperative Antiseptic in Newborn Circumcision Comparison of Povidone Iodine and Hypochlorous Acid Used

NCT ID: NCT05175027

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2021-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of Povidone iodine and Hypochlorous acid used as a Preoperative Antiseptic in Newborn Circumcision abstract

Aim:

Circumcision is one of the most common surgical procedures in all age groups. Before the circumcision procedure, asepsis is provided with a surface disinfectant. Various methods can be used for this process. Povidone iodine, which has been used for years during the transition from traditional circumcision methods to surgical circumcision methods; tissue damage, allergic reactions and increase in pain level. For this reason, the investigators aimed to compare it with Hypochlorous acid (Crystalin), which is a less toxic and more physiological antiseptic solution.

Material and Method:

Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group. At the beginning of the circumcision procedure, a culture was taken in the form of a prepucial swab 1 minute after the cleaning of the local area and the inner surface of the prepuce. Then circumcision was performed. Culture results and complications were compared.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is aimed to compare two solutions used for cleaning the operation area in newborn circumcision.It was conducted to compare the antibacterial activity of povidone iodine and hypochlorous.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn; Infection Disinfection Circumcision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypochlorosis

Hypochlorosis was used as an antiseptic for the patients

Group Type ACTIVE_COMPARATOR

hypochlorous acid

Intervention Type DRUG

Randomize

Povidone iodine

Povidone iodine was used as an antiseptic for the patients

Group Type ACTIVE_COMPARATOR

hypochlorous acid

Intervention Type DRUG

Randomize

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hypochlorous acid

Randomize

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

povidone iodine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male
* newborn,

Exclusion Criteria

* hipospadias,
* epispadias,
* urinary infectious
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hisar Intercontinental Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Basri Cakiroglu

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Basri Cakiroglu

Role: STUDY_DIRECTOR

Hisar Intercontinental Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hisar Intercontinental Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.