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Completed

NCT Number: NCT05175027

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

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.

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Key information

Age range

1 day–1 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male
  • newborn,

Exclusion criteria

  • hipospadias,
  • epispadias,
  • urinary infectious

Treatment and study plan

Hypochlorous Acid

Drug

Randomize

Other names: povidone iodine

Primary outcomes

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

    Time frame: one month

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

  2. 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

Sponsors and collaborators

Lead sponsor

Hisar Intercontinental Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2022
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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