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

Sponsor
Hisar Intercontinental Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05175027
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6.2
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: hypochlorous acid
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
"Comparison of Povidone Iodine and Hypochlorous Acid Used as a Preoperative Antiseptic in Neonatal Circumcision"
Actual Study Start Date :
May 5, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Nov 11, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effect of both drugs on wound healing will be investigated. [one month]

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

    2. The effect of both drugs on antibacterial effects will be investigated [one week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 1 Month
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • male

    • newborn,

    Exclusion Criteria:

    • hipospadias,

    • epispadias,

    • urinary infectious

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hisar Intercontinental Hospital Istanbul Turkey 34768

    Sponsors and Collaborators

    • Hisar Intercontinental Hospital

    Investigators

    • Study Director: Basri Cakiroglu, Hisar Intercontinental Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Basri Cakiroglu, Ass. Prof., Hisar Intercontinental Hospital
    ClinicalTrials.gov Identifier:
    NCT05175027
    Other Study ID Numbers:
    • 2021/15
    First Posted:
    Jan 3, 2022
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Basri Cakiroglu, Ass. Prof., Hisar Intercontinental Hospital
    circumcision,
    wound
    antibacterial
    Additional relevant MeSH terms:
    Povidone-Iodine
    Povidone

    Study Results

    No Results Posted as of Jan 3, 2022