PhimosisCircglueNCT01794221
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
A study testing stitches and skin adhesive and stitches only in people with Phimosis and Adhesions, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive. Read more about this study
- Who is it for?
- Ages 1 day to 7 years, men only
- What is being tested?
- stitches and skin adhesive and stitches only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2017
- 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 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All patients undergoing circumcision
- Only male patients under the age of 7 years will be eligible
Who cannot join
- Any patient over 7 years of age
- Previous circumcision
- Any parents who are not English language speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.
Read the detailed description
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.
Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.
- Being tested
- stitches and skin adhesive, stitches only
- Keywords
- circumcision, 2 octyl cyanoacrylate, phimosis
- Medical subject headings
- Phimosis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stitches and skin adhesiveProcedure or surgery
Also called skin adhesive
In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.
stitches onlyProcedure or surgery
standard of care
| Study group | Role | What they receive |
|---|---|---|
| Stitches only | Active comparator | Stitches only closing circumcision wound Receives: Procedure: stitches only |
| Stitches and skin adhesive | Experimental | application of 2-octyl cyanoacrylate skin adhesive. Receives: Procedure: stitches and skin adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post circumcision adhesions
Evaluation for adhesions
Measured: 3-6 weeks
Secondary outcomes (1)
Parent satisfaction and comfort level with circumcision results
Parent survey at follow-up visit.
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhimosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794221
- Sponsor's protocol ID
- 1290443
- Acronym
- Circglue
- Status last verified
- Jan 2019
- First submitted
- 15 Feb 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
- ClinicalTrials.gov ID
- NCT01794221
- Acronym / sponsor ID
- Circglue / 1290443
- Keywords
- circumcision, 2 octyl cyanoacrylate, phimosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Feb 2013 (estimated)
- 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.
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.
Detailed description
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.
Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stitches only | Active comparator | Procedure: stitches onlyStitches only closing circumcision wound |
| Stitches and skin adhesive | Experimental | Procedure: stitches and skin adhesiveapplication of 2-octyl cyanoacrylate skin adhesive. |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All patients undergoing circumcision
- Only male patients under the age of 7 years will be eligible
Key exclusion criteria (3 listed)
- Any patient over 7 years of age
- Previous circumcision
- Any parents who are not English language speaking
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 |
|---|---|---|
| stitches and skin adhesiveAlso: skin adhesiveIn addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound. | Procedure or surgery | Stitches and skin adhesive |
| stitches onlystandard of care | Procedure or surgery | Stitches only |
Primary outcome
Post circumcision adhesions
Time frame: 3-6 weeks
Evaluation for adhesions
1 secondary outcome
Parent satisfaction and comfort level with circumcision results
Time frame: 3-6 weeks
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 10 Jan 2019.
- 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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stitches and skin adhesive and stitches only in people with Phimosis and Adhesions, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 10 Jan 2019. 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 United States. 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?
Post circumcision adhesions (time frame: 3-6 weeks). 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 10 Jan 2019.