Redundant PrepucePhase 3NCT04908137
Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
A Phase 3 study testing 2-octyl cyanoacrylate in people with Redundant Prepuce, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Study Description: 2-Octyl Cyanoacrylate (Dermabond) use in neonatal circumcision are being practiced to prevent complications; however, no randomized controlled trials was ever done to assess efficacy and safety. Read more about this study
- Who is it for?
- Ages 2 to 60 days, men only
- Conditions the study is for
- Redundant Prepuce
- What is being tested?
- 2-octyl cyanoacrylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 31 Dec 2024
- Phase
- Phase 3
- 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 2 to 60 days
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Consent provided by one of the parents
- Male sex eligible for neonatal circumcision (with no genital anomalies, such as hypospadias components or congenital curvatures)
- Aged 2 to 60 days
- In good general health as evidenced by medical history
- No history of hematological diseases with clotting or bleeding disorders such as hemophilia, Von Willebrand diseases
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Presence of bleeding or clotting disorders
- Family history of bleeding or clotting disorder
- Genital anomalies such as hypospadias, severe ventral curvatures
- Known allergic reactions to components of the 2-Octyl Cyanoacrylate (Dermabond)
- Febrile illness within 48hrs
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or the delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Katie Baker, 4168136917, katie.baker@sickkids.ca
Barbara Pannozzo, RN, 4168136917, urology.nurses@sickkids.ca
About this study
Study Description: 2-Octyl Cyanoacrylate (Dermabond) use in neonatal circumcision are being practiced to prevent complications; however, no randomized controlled trials was ever done to assess efficacy and safety. This is a single-centered, randomized clinical trial to assess the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision to prevent complication.
Primary Objective: To determine the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application versus control in neonatal circumcision to prevent post-procedural complication.
Read more
Secondary Objectives:
- To assess post-procedural pain score difference between with versus without 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision
- To assess parents' satisfaction and cosmesis post-neonatal circumcision with versus without 2-Octyl Cyanoacrylate (Dermabond) application.
Endpoints: Primary Endpoint: Complication rates post-neonatal circumcision within 180 days with the following complication in specific or in composite ⦁ Bleeding requiring hemostatic intervention (suturing, dermabond application, silver nitrite application, pressure bandage)
- Infection requiring antibiotic administration or wound drainage
- Excess skin as assessed by parents satisfaction
- Meatal stenosis
- Adhesion requiring surgical correction.
Secondary Endpoints:
- pain score within 5 min and 30 minutes postneonatal circumcision using the FLACC score by parents and MBPS scale by a medical allied personnel.
- Parents satisfaction as determined by a simple 10-score liked scale and cosmesis assessment scale within 24hrs and within 30 days post-neonatal circumcision. Complication rates detailed above in specific time points clustered according to (within 24 hrs, within 2 weeks, within 30 days, within 30 to 180 days).
Study Population: 280 male neonates (140 each intervention groups) who are eligible for neonatal circumcision with no other medical co-morbidities.
Intervention:
2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks) topical application around post-circumcision site subcoronal area.
- Conditions
- Redundant Prepuce
- Being tested
- 2-octyl cyanoacrylate
- Keywords
- Circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octyl cyanoacrylateDrug
Also called Dermabond
Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D \& C Violet No. 2. It is provided as a single use applicator in a blister package
| Study group | Role | What they receive |
|---|---|---|
| 2-Octyl Cyanoacrylate (Dermabond) Group | Experimental | 2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks topical application around post-circumcision site subcoronal area immediately after the circumcision devise is removed and circumcision procedure was done Receives: Drug: 2-octyl cyanoacrylate |
| Control Group | No intervention | will receive Vaseline cream application around the post-circumcision site immediately after circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates (Composite)
Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision
Measured: 180 days post neonatal circumcision
Secondary outcomes (4)
Pain score (FLACC) by Parents
pain score within 5 minutes post-neonatal circumcision using the FLACC score by parents. (Higher Score is Worse)
Measured: 5 minutes and 30 minutes
Pain score (MBPS) by Medical Personnel
pain score within 5 minutes and 30 minutes post-neonatal circumcision using the MBPS scale by a medical allied personnel. (Higher Score is Worse)
Measured: 5 minutes and 30 minutes
Parents Satisfaction
Parents satisfaction as determined by a simple 10-score liked scale and cosmetic assessment scale within 24hours and within 30 days post-neonatal circumcision
Measured: within 24 hours and 30 days post neonatal circumcision
Complication rates (specific case characteristics)
Complication rates post-neonatal circumcision
Measured: within 24 hours, within 2 weeks, within 30 days within 30 to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Redundant PrepuceStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chua, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908137
- Sponsor's protocol ID
- 1000070281
- Status last verified
- Oct 2021
- First submitted
- 26 May 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 2-Octyl Cyanoacrylate (Dermabond) in Neonatal Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04908137
- Acronym / sponsor ID
- 1000070281
- Conditions
- Redundant Prepuce
- Keywords
- Circumcision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Jun 2021 (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.
Study Description: 2-Octyl Cyanoacrylate (Dermabond) use in neonatal circumcision are being practiced to prevent complications; however, no randomized controlled trials was ever done to assess efficacy and safety. This is a single-centered, randomized clinical trial to assess the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision to prevent complication.
Primary Objective: To determine the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application versus control in neonatal circumcision to prevent post-procedural complication.
Secondary Objectives:
- To assess post-procedural pain score difference between with versus without 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision
- To assess parents' satisfaction and cosmesis post-neonatal circumcision with versus without 2-Octyl Cyanoacrylate (Dermabond) application.
Endpoints: Primary Endpoint: Complication rates post-neonatal circumcision within 180 days with the following complication in specific or in composite ⦁ Bleeding requiring hemostatic intervention (suturing, dermabond application, silver nitrite application, pressure bandage)
- Infection requiring antibiotic administration or wound drainage
- Excess skin as assessed by parents satisfaction
- Meatal stenosis
- Adhesion requiring surgical correction.
Secondary Endpoints:
- pain score within 5 min and 30 minutes postneonatal circumcision using the FLACC score by parents and MBPS scale by a medical allied personnel.
- Parents satisfaction as determined by a simple 10-score liked scale and cosmesis assessment scale within 24hrs and within 30 days post-neonatal circumcision. Complication rates detailed above in specific time points clustered according to (within 24 hrs, within 2 weeks, within 30 days, within 30 to 180 days).
Study Population: 280 male neonates (140 each intervention groups) who are eligible for neonatal circumcision with no other medical co-morbidities.
Intervention:
2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks) topical application around post-circumcision site subcoronal area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-Octyl Cyanoacrylate (Dermabond) Group | Experimental | Drug: 2-octyl cyanoacrylate2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks topical application around post-circumcision site subcoronal area immediately after the circumcision devise is removed and circumcision procedure was done |
| Control Group | No intervention | –will receive Vaseline cream application around the post-circumcision site immediately after circumcision |
Who may qualify
- Ages
- 2 to 60 days
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Consent provided by one of the parents
- Male sex eligible for neonatal circumcision (with no genital anomalies, such as hypospadias components or congenital curvatures)
- Aged 2 to 60 days
- In good general health as evidenced by medical history
- No history of hematological diseases with clotting or bleeding disorders such as hemophilia, Von Willebrand diseases
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| 2-octyl cyanoacrylateAlso: DermabondTopical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D \& C Violet No. 2. It is provided as a single use applicator in a blister package | Drug | 2-Octyl Cyanoacrylate (Dermabond) Group |
Primary outcome
Complication rates (Composite)
Time frame: 180 days post neonatal circumcision
Composite complication rates post-neonatal circumcision within 180 days following neonatal circumcision
4 secondary outcomes
Pain score (FLACC) by Parents
Time frame: 5 minutes and 30 minutes
Pain score (MBPS) by Medical Personnel
Time frame: 5 minutes and 30 minutes
Parents Satisfaction
Time frame: within 24 hours and 30 days post neonatal circumcision
Complication rates (specific case characteristics)
Time frame: within 24 hours, within 2 weeks, within 30 days within 30 to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2-octyl cyanoacrylate in people with Redundant Prepuce, run by The Hospital for Sick Children at 1 site in Canada.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael E Chua, MD (4168136899, michael.chua@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rates (Composite) (time frame: 180 days post neonatal circumcision). 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 15 Oct 2021.