Newborn; InfectionNCT05175027
Preoperative Antiseptic in Newborn Circumcision Comparison of Povidone Iodine and Hypochlorous Acid Used
A study testing hypochlorous acid in people with Newborn; Infection and Disinfection, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 1 month, men onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn; Infection, Disinfection, Circumcision
- What is being tested?
- hypochlorous acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- male
- newborn,
Who cannot join
- hipospadias,
- epispadias,
- urinary infectious
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: "Comparison of Povidone Iodine and Hypochlorous Acid Used as a Preoperative Antiseptic in Neonatal Circumcision"
Comparison of Povidone iodine and Hypochlorous acid used as a Preoperative Antiseptic in Newborn Circumcision abstract
Aim:
Read more
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.
- Conditions
- Newborn; Infection, Disinfection, Circumcision
- Being tested
- hypochlorous acid
- Keywords
- circumcision,, wound, antibacterial
- Medical subject headings
- Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypochlorous acidDrug
Also called povidone iodine
Randomize
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorosis | Active comparator | Hypochlorosis was used as an antiseptic for the patients Receives: Drug: hypochlorous acid |
| Povidone iodine | Active comparator | Povidone iodine was used as an antiseptic for the patients Receives: Drug: hypochlorous acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of both drugs on wound healing will be investigated.
there is wound healing;1,no wound healing:0
Measured: one month
The effect of both drugs on antibacterial effects will be investigated
there is bacterial growth:1, there is no bacterial growth:0
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start5 May 2021
- Primary completion30 Oct 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
- Investigators
- Basri Cakiroglu, Study director, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175027
- Sponsor's protocol ID
- 2021/15
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Povidone Iodine and Hypochlorous Acid Used as a Preoperative Antiseptic in Neonatal Circumcision"
- ClinicalTrials.gov ID
- NCT05175027
- Acronym / sponsor ID
- 2021/15
- Conditions
- Newborn; Infection, Disinfection, Circumcision
- Keywords
- circumcision,, wound, antibacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
| Arm | Type | Receives |
|---|---|---|
| Hypochlorosis | Active comparator | Drug: hypochlorous acidHypochlorosis was used as an antiseptic for the patients |
| Povidone iodine | Active comparator | Drug: hypochlorous acidPovidone iodine was used as an antiseptic for the patients |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male
- newborn,
Key exclusion criteria (3 listed)
- hipospadias,
- epispadias,
- urinary infectious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypochlorous acidAlso: povidone iodineRandomize | Drug | Hypochlorosis, Povidone iodine |
Primary outcome
The effect of both drugs on wound healing will be investigated.
Time frame: one month
there is wound healing;1,no wound healing:0
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basri Cakiroglu study director
Hisar Intercontinental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypochlorous acid in people with Newborn; Infection and Disinfection, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of both drugs on wound healing will be investigated. (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.