Pilonidal Sinus TreatmentNCT06741449
The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease
A study testing keystone flap and lay open in people with Pilonidal Sinus Treatment, run by Zagazig University at 1 site in Egypt.
Trial summary
Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Treatment
- What is being tested?
- keystone flap and lay open
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- re-recurrent pilonidal disease
Who cannot join
- patients with proved anal or perineal malignancy or autoimmune disease
- patient with pilonidal disease for the first time or for the first time of recurrence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease ( Two Times of Recurrence or More): One Year Experience Study
Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.
- Conditions
- Pilonidal Sinus Treatment
- Being tested
- keystone flap, lay open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keystone flapProcedure or surgery
facio-cutaneous flap used to cover the defect after removal of the disease
lay openProcedure or surgery
after removal of the disease, the wound is left open to heal by granulation tissue
| Study group | Role | What they receive |
|---|---|---|
| re- recurrent pilonidal sinus | Active comparator | Not described Receives: Procedure: keystone flap |
| re-recurrent pilonidal sinus | Active comparator | Not described Receives: Procedure: lay open |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Measured: operative time is measured in minutes from incision to wound dressing
bleeding amount
intra and post operative bleeding amount is measured in cc by volumetric method
Measured: amount of blood lost is measured from incision for 2 days post operative
healing time
Measured: healing time is measured for 3 months post-operatively
wound infection
wound infection evaluated by presence of pus from the first day post-operativel
Measured: wound infection is evaluated for 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus TreatmentStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741449
- Sponsor's protocol ID
- #881\8-Dec-2024
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available on demand by contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease ( Two Times of Recurrence or More): One Year Experience Study
- ClinicalTrials.gov ID
- NCT06741449
- Acronym / sponsor ID
- #881\8-Dec-2024
- Conditions
- Pilonidal Sinus Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 19 Dec 2024 (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.
Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| re- recurrent pilonidal sinus | Active comparator | Procedure: keystone flap |
| re-recurrent pilonidal sinus | Active comparator | Procedure: lay open |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- re-recurrent pilonidal disease
Key exclusion criteria (2 listed)
- patients with proved anal or perineal malignancy or autoimmune disease
- patient with pilonidal disease for the first time or for the first time of recurrence
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 |
|---|---|---|
| keystone flapfacio-cutaneous flap used to cover the defect after removal of the disease | Procedure or surgery | re- recurrent pilonidal sinus |
| lay openafter removal of the disease, the wound is left open to heal by granulation tissue | Procedure or surgery | re-recurrent pilonidal sinus |
Primary outcome
operative time
Time frame: operative time is measured in minutes from incision to wound dressing
bleeding amount
Time frame: amount of blood lost is measured from incision for 2 days post operative
intra and post operative bleeding amount is measured in cc by volumetric method
healing time
Time frame: healing time is measured for 3 months post-operatively
wound infection
Time frame: wound infection is evaluated for 3 months post-operatively
wound infection evaluated by presence of pus from the first day post-operativel
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 17 Aug 2025.
- Individual participant dataSharing planned: Undecided. data will be available on demand by contacting the principle investigator
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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 study testing keystone flap and lay open in people with Pilonidal Sinus Treatment, run by Zagazig 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 2 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 17 Aug 2025. 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?
operative time (time frame: operative time is measured in minutes from incision to wound dressing). The study lists 4 primary outcomes in all. 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 17 Aug 2025.