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

NCT05175027 | Completed

• 1 other identifier: 2021/15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newborn; Infection; Disinfection; Circumcision

Keywords

circumcision,; wound; antibacterial

Outcome Measures

Primary Outcomes (2)

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

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

  one month

• The effect of both drugs on antibacterial effects will be investigated

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

  one week

Study Arms (2)

Hypochlorosis

ACTIVE COMPARATOR

Hypochlorosis was used as an antiseptic for the patients

Drug: hypochlorous acid

Povidone iodine

ACTIVE COMPARATOR

Povidone iodine was used as an antiseptic for the patients

Drug: hypochlorous acid

Interventions

hypochlorous acid DRUG

Randomize

Also known as: povidone iodine

Hypochlorosis; Povidone iodine

Eligibility Criteria

• Age: 1 Day - 1 Month
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• male
• newborn,

You may not qualify if:

• hipospadias,
• epispadias,
• urinary infectious

Sponsors & Collaborators

• Hisar Intercontinental Hospital: lead

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections; Wounds and Injuries

Interventions

Hypochlorous Acid; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds; Iodophors; Iodine Compounds; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Basri Cakiroglu

  Hisar Intercontinental Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

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

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: January 3, 2022
• Study Start: May 5, 2021
• Primary Completion: October 30, 2021
• Study Completion: November 11, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)