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

December 30, 2021 updated by: Basri Cakiroglu, Hisar Intercontinental Hospital

"Comparison of Povidone Iodine and Hypochlorous Acid Used as a Preoperative Antiseptic in Neonatal Circumcision"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34768
        • Hisar Intercontinental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • newborn,

Exclusion Criteria:

  • hipospadias,
  • epispadias,
  • urinary infectious

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypochlorosis
Hypochlorosis was used as an antiseptic for the patients
Drug: hypochlorous acid
Randomize
Other Names:
  • povidone iodine
Active Comparator: Povidone iodine
Povidone iodine was used as an antiseptic for the patients
Drug: hypochlorous acid
Randomize
Other Names:
  • povidone iodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of both drugs on wound healing will be investigated.
Time Frame: one month
there is wound healing;1,no wound healing:0
one month
The effect of both drugs on antibacterial effects will be investigated
Time Frame: one week
there is bacterial growth:1, there is no bacterial growth:0
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hisar Intercontinental Hospital

Investigators

  • Study Director: Basri Cakiroglu, Hisar Intercontinental Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

November 11, 2021

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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