Pilonidal SinusNCT01792557
Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
A study testing Crystallized phenol, Limberg Flap and Modified Limberg Flap in people with Pilonidal Sinus, run by S.B. Konya Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Crystallized phenol, Limberg Flap and Modified Limberg Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Mar 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pilonidal disease
Who cannot join
- Previous history of pilonidal disease treatment
- Pregnant or breast-feeding women
- Systemic diseases that would affect wound healing
- Diabetes
- Chronic renal failure
- Autoimmune diseases
- Malignant diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Education and Research Hospital
Meram, Konya, 42040
About this study
Official title: Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
Read the detailed description
Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
- Conditions
- Pilonidal Sinus
- Being tested
- Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis Flap
- Keywords
- Pilonidal sinus, Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis, Recurrence, Complications, Recovery duration, Time to return to work
- Medical subject headings
- Pilonidal Sinus, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystallized phenolDrug
Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks.
Limberg FlapProcedure or surgery
Limberg Flap surgery for pilonidal disease treatment
Modified Limberg FlapProcedure or surgery
Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.
Karydakis FlapProcedure or surgery
Karydakis Flap surgery for pilonidal disease treatment
| Study group | Role | What they receive |
|---|---|---|
| Phenol | Active comparator | Crystallized Phenol Group Receives: Drug: Crystallized phenol |
| Limberg | Active comparator | Limberg Flap Group Receives: Procedure: Limberg Flap |
| Modified Limberg | Active comparator | Modified Limberg Flap Group Receives: Procedure: Modified Limberg Flap |
| Karydakis | Active comparator | Karydakis Flap Group Receives: Procedure: Karydakis Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of recurrence
Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.
Measured: 3rd year
Secondary outcomes (3)
Assessment of patient comfort
Patients will be queried for patient comfort at the end of first year
Measured: 1st year
Assessment of recovery duration
Post procedure wound recovery duration will be recorded
Measured: 3rd month
Assessment of complications
Patients will be followed up for procedure related complications.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.B. Konya Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Doğru, M.D., Study director, Konya Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792557
- Sponsor's protocol ID
- KEAH06021301
- Other IDs
- U1111-1139-3538
- Status last verified
- Mar 2014
- First submitted
- 11 Feb 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.
PubMed 15622588Akin M, Leventoglu S, Mentes BB, Bostanci H, Gokbayir H, Kilic K, Ozdemir E, Ferahkose Z. Comparison of the classic Limberg flap and modified Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010 Aug;40(8):757-62. doi: 10.1007/s00595-008-4098-7. Epub 2010 Jul 30.
PubMed 20676861Keshava A, Young CJ, Rickard MJ, Sinclair G. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg. 2007 Mar;77(3):181-3. doi: 10.1111/j.1445-2197.2006.04003.x.
PubMed 17305997Cihan A, Mentes BB, Tatlicioglu E, Ozmen S, Leventoglu S, Ucan BH. Modified Limberg flap reconstruction compares favourably with primary repair for pilonidal sinus surgery. ANZ J Surg. 2004 Apr;74(4):238-42. doi: 10.1111/j.1445-2197.2004.02951.x.
PubMed 15043735
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01792557
- Acronym / sponsor ID
- KEAH06021301
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis, Recurrence, Complications, Recovery duration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- S.B. Konya Education and Research HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 15 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.
Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
Detailed description
Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenol | Active comparator | Drug: Crystallized phenolCrystallized Phenol Group |
| Limberg | Active comparator | Procedure: Limberg FlapLimberg Flap Group |
| Modified Limberg | Active comparator | Procedure: Modified Limberg FlapModified Limberg Flap Group |
| Karydakis | Active comparator | Procedure: Karydakis FlapKarydakis Flap Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pilonidal disease
Key exclusion criteria (7 listed)
- Previous history of pilonidal disease treatment
- Pregnant or breast-feeding women
- Systemic diseases that would affect wound healing
- Diabetes
- Chronic renal failure
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 |
|---|---|---|
| Crystallized phenolCrystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks. | Drug | Phenol |
| Limberg FlapLimberg Flap surgery for pilonidal disease treatment | Procedure or surgery | Limberg |
| Modified Limberg FlapLimberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area. | Procedure or surgery | Modified Limberg |
| Karydakis FlapKarydakis Flap surgery for pilonidal disease treatment | Procedure or surgery | Karydakis |
Primary outcome
Assessment of recurrence
Time frame: 3rd year
Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.
3 secondary outcomes
Assessment of patient comfort
Time frame: 1st year
Assessment of recovery duration
Time frame: 3rd month
Assessment of complications
Time frame: 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Background: PubMed 15622588Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.
- Background: PubMed 20676861Akin M, Leventoglu S, Mentes BB, Bostanci H, Gokbayir H, Kilic K, Ozdemir E, Ferahkose Z. Comparison of the classic Limberg flap and modified Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010 Aug;40(8):757-62. doi: 10.1007/s00595-008-4098-7. Epub 2010 Jul 30.
- Background: PubMed 17305997Keshava A, Young CJ, Rickard MJ, Sinclair G. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg. 2007 Mar;77(3):181-3. doi: 10.1111/j.1445-2197.2006.04003.x.
- Background: PubMed 15043735Cihan A, Mentes BB, Tatlicioglu E, Ozmen S, Leventoglu S, Ucan BH. Modified Limberg flap reconstruction compares favourably with primary repair for pilonidal sinus surgery. ANZ J Surg. 2004 Apr;74(4):238-42. doi: 10.1111/j.1445-2197.2004.02951.x.
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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.
Osman Doğru, M.D. study director
Konya Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystallized phenol, Limberg Flap and Modified Limberg Flap in people with Pilonidal Sinus, run by S.B. Konya Education and Research Hospital at 1 site in Turkey (Türkiye).
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 7 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: status not confirmed, as of the sponsor's last update on 24 Mar 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Assessment of recurrence (time frame: 3rd year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792557, which also lists 4 linked publications.
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 24 Mar 2014.