Pilonidal SinusPhase 1NCT01399320
Ghnnam Excision Technique for Pilonidal Sinus
A Phase 1 study testing cyanoacrylate in people with Pilonidal Sinus and Surgical Wound, run by Mansoura University at 1 site in Egypt.
Trial summary
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate
- What is being tested?
- cyanoacrylate
- 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
- Aug 2008to Jun 2010
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any patient with pilonidal sinus
Who cannot join
- pilonidal abscess or sever acute inflammation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Faculty of Medicine
Al Mansurah, Dakahlia Governorate, 35665
About this study
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition
Read the detailed description
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing
- Conditions
- Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate
- Being tested
- cyanoacrylate
- Keywords
- Pilonidal disease, Excision, cyanoacrylate
- Medical subject headings
- Pilonidal Sinus, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylateProcedure or surgery
Also called histoacryl
excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing
| Study group | Role | What they receive |
|---|---|---|
| cyanoacrylate dressing,excesion | Experimental | we excise the sinus tip then apply cyanoacrylate dressing and watch for healing Receives: Procedure: cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of the sinus
Measured: 1 month
Secondary outcomes (3)
recurrence
no recurrence
Measured: 1 year
wound infection
occurrence of wound sepsis
Measured: 3-6 months
patient satisfaction
patient satisfied with the procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- wagih m ghnnam, MD, Principal investigator, mansoura faculty of medicine general surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399320
- Sponsor's protocol ID
- MansouraU
- Status last verified
- Aug 2008
- First submitted
- 19 Jul 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghnnam Excision Technique for Pilonidal Sinus
- ClinicalTrials.gov ID
- NCT01399320
- Acronym / sponsor ID
- MansouraU
- Conditions
- Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate
- Keywords
- Pilonidal disease, Excision, cyanoacrylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Jul 2011 (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.
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition
Detailed description
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cyanoacrylate dressing,excesion | Experimental | Procedure: cyanoacrylatewe excise the sinus tip then apply cyanoacrylate dressing and watch for healing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any patient with pilonidal sinus
Key exclusion criteria (1 listed)
- pilonidal abscess or sever acute inflammation
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 |
|---|---|---|
| cyanoacrylateAlso: histoacrylexcision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing | Procedure or surgery | cyanoacrylate dressing,excesion |
Primary outcome
healing of the sinus
Time frame: 1 month
3 secondary outcomes
recurrence
Time frame: 1 year
wound infection
Time frame: 3-6 months
patient satisfaction
Time frame: 3 months
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 21 Jul 2011.
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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.
wagih m ghnnam, MD principal investigator
mansoura faculty of medicine general surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cyanoacrylate in people with Pilonidal Sinus and Surgical Wound, 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 21 Jul 2011. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
healing of the sinus (time frame: 1 month). 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 21 Jul 2011.