Pilonidal Sinus DisorderNCT02638064
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
A study testing Surgiflo injection in people with Pilonidal Sinus Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
Assessment of surgiflo injection for treating pilonidal sinus disease Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Pilonidal Sinus Disorder
- What is being tested?
- Surgiflo injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Nov 2015
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study
Who cannot join
- We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of surgiflo injection for treating pilonidal sinus disease
Read the detailed description
Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up
- Conditions
- Pilonidal Sinus Disorder
- Being tested
- Surgiflo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgiflo injectionProcedure or surgery
Curettage of sinus cavity then injection of surgiflo material
| Study group | Role | What they receive |
|---|---|---|
| Surgiflo injection | Experimental | Injection of surgiflo in the pilonidal sinus cavity after curettage of its content Receives: Procedure: Surgiflo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of the condition
number of patients presenting with recurrent pilonidal sinus
Measured: 2 years
Secondary outcomes (1)
Complications of the procedure
number of patients presenting with complications after injection of surgiflo
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Hosam Elbanna, M.D, Principal investigator, private basis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638064
- Sponsor's protocol ID
- mansourau25
- Status last verified
- Dec 2015
- First submitted
- 29 Oct 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
- ClinicalTrials.gov ID
- NCT02638064
- Acronym / sponsor ID
- mansourau25
- Conditions
- Pilonidal Sinus Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Dec 2015 (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.
Assessment of surgiflo injection for treating pilonidal sinus disease
Detailed description
Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgiflo injection | Experimental | Procedure: Surgiflo injectionInjection of surgiflo in the pilonidal sinus cavity after curettage of its content |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study
Key exclusion criteria (1 listed)
- We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.
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 |
|---|---|---|
| Surgiflo injectionCurettage of sinus cavity then injection of surgiflo material | Procedure or surgery | Surgiflo injection |
Primary outcome
Recurrence of the condition
Time frame: 2 years
number of patients presenting with recurrent pilonidal sinus
1 secondary outcome
Complications of the procedure
Time frame: 2 years
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 22 Dec 2015.
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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.
Hosam Elbanna, M.D principal investigator
private basis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgiflo injection in people with Pilonidal Sinus Disorder, run by Mansoura 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 1 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 22 Dec 2015. 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.
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?
Recurrence of the condition (time frame: 2 years). 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 22 Dec 2015.