HypospadiasPhase 2/3NCT04876976
Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair
A Phase 2/3 study testing Cyanoacrylate, Isobutyl and Classic surgical repair in people with Hypospadias, run by Ain Shams University at 1 site in Egypt.
Trial summary
cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Cyanoacrylate, Isobutyl and Classic surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Jan 2020
- Phase
- Phase 2/3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Urethro-cutaneous fistula regardless of their age were included in our study.
Who cannot join
- Patients with fistula size more than 5 mm
- multiple fistulas
- uncorrected obstruction distal to the fistula
- necrotic tissue
- active infection at the fistula site
- severely scarred skin
Show all 10Show fewer
- deficient dartos around the fistula
- fistulas more proximal to the mid penile position
- recurrent fistulas
- previous history of hypersensitivity to cyanoacrylate-based products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.
cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair
Read the detailed description
Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair.
cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias
this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique
- Conditions
- Hypospadias
- Being tested
- Cyanoacrylate, Isobutyl, Classic surgical repair
- Keywords
- Isoamyl 2-cyanoacrylate, urethrocutaneous fistula, fistula repair, hypospadias
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate, IsobutylDrug
using cyanoacrylate in the surgical repair of urethro-cutaneous fistula
Classic surgical repairProcedure or surgery
classical repair of urethro-cutaneous fistula without the use of cyanoacryalte
| Study group | Role | What they receive |
|---|---|---|
| Cases of group (I) cyanoacrylate glue | Experimental | Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. Receives: Drug: Cyanoacrylate, Isobutyl |
| Cases of the control group (II) , classic repair | Active comparator | Cases of the control group (II) underwent the same procedure without using cyanoacrylate. Receives: Procedure: Classic surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful repair of the fistula
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
Measured: 6 months after surgery
Secondary outcomes (1)
postoperative complications
report of the possible postoperative complications of both groups
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876976
- Sponsor's protocol ID
- MS 75/2018
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04876976
- Acronym / sponsor ID
- MS 75/2018
- Conditions
- Hypospadias
- Keywords
- Isoamyl 2-cyanoacrylate, urethrocutaneous fistula, fistula repair, hypospadias
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 May 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.
cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair
Detailed description
Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair.
cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias
this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
| Arm | Type | Receives |
|---|---|---|
| Cases of group (I) cyanoacrylate glue | Experimental | Drug: Cyanoacrylate, IsobutylCases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer. |
| Cases of the control group (II) , classic repair | Active comparator | Procedure: Classic surgical repairCases of the control group (II) underwent the same procedure without using cyanoacrylate. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Urethro-cutaneous fistula regardless of their age were included in our study.
Key exclusion criteria (10 listed)
- Patients with fistula size more than 5 mm
- multiple fistulas
- uncorrected obstruction distal to the fistula
- necrotic tissue
- active infection at the fistula site
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 |
|---|---|---|
| Cyanoacrylate, Isobutylusing cyanoacrylate in the surgical repair of urethro-cutaneous fistula | Drug | Cases of group (I) cyanoacrylate glue |
| Classic surgical repairclassical repair of urethro-cutaneous fistula without the use of cyanoacryalte | Procedure or surgery | Cases of the control group (II) , classic repair |
Primary outcome
successful repair of the fistula
Time frame: 6 months after surgery
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
1 secondary outcome
postoperative complications
Time frame: 6 months after surgery
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 7 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyanoacrylate, Isobutyl and Classic surgical repair in people with Hypospadias, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 10 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 7 May 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
successful repair of the fistula (time frame: 6 months after surgery). 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 7 May 2021.