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

Circumcision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175027
• Other study ID #: 2021/15
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: November 11, 2021

Study information

• Verified date: December 2021
• Source: Hisar Intercontinental Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 11, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• male

• newborn,

Exclusion Criteria:

• hipospadias,

• epispadias,

• urinary infectious

Related Conditions & MeSH terms

• Circumcision
• Disinfection
• Newborn; Infection

Intervention

Drug:
• hypochlorous acid
Randomize

Locations

Country	Name	City	State
Turkey	Hisar Intercontinental Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Hisar Intercontinental Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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