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CompletedNCT05175027Updated Jan 3, 2022

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

An interventional study of hypochlorous acid in Newborn; Infection, Disinfection and Circumcision, sponsored by Hisar Intercontinental Hospital. Completed at 1 site in Turkey. Open to male participants aged 1 Day to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.

Sponsored by Hisar Intercontinental Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Day to 1 Month
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Newborn; Infection
  • Disinfection
  • Circumcision

Keywords

  • circumcision,
  • wound
  • antibacterial
03

In context

Lead sponsor

Hisar Intercontinental Hospital is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Month
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • male
  • newborn,

Exclusion criteria

Exclusion Criteria:

  • hipospadias,
  • epispadias,
  • urinary infectious
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Hypochlorosis

    Hypochlorosis was used as an antiseptic for the patients

    Drug: hypochlorous acid

  • Active comparator
    Povidone iodine

    Povidone iodine was used as an antiseptic for the patients

    Drug: hypochlorous acid

Interventions

  • Drughypochlorous acid

    Randomize

    Also known as: povidone iodine

06

What researchers measure

Primary outcomes

  1. The effect of both drugs on wound healing will be investigated.

    there is wound healing;1,no wound healing:0

    Time frame: one month

  2. The effect of both drugs on antibacterial effects will be investigated

    there is bacterial growth:1, there is no bacterial growth:0

    Time frame: one week

07

Study locations

1 site
  • Hisar Intercontinental Hospital
    Istanbul, 34768, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05175027
Lead sponsor
Hisar Intercontinental Hospital
Responsible party
Basri Cakiroglu (Ass. Prof., Hisar Intercontinental Hospital) — Principal investigator
First posted
Jan 3, 2022
Start date
May 5, 2021
Primary completion
Oct 30, 2021
Completion
Nov 11, 2021
Last update
Jan 3, 2022

Study contacts

Basri Cakiroglu
study director · Hisar Intercontinental Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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