Pilonidal SinusNCT06517472
Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
An observational study of Pilonidal Sinus, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pilonidal Sinus
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Oct 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Female patients aged 18 and older with pilonidal sinus disease and two or fewer pits, with no previous surgical treatment.
Who may be able to join
- Having two pits or less
Who cannot join
- With bilateral lateral extension,
- Stage-R with recurrent disease
- Number of pits more than three pits,
- Collagen tissue disease,
- Patients with a postoperative follow-up period of less than 12 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Other, 34785
Adnan Gundogdu, +905367173909, adnangundogdu89@gmail.com
About this study
Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.
Read the detailed description
Pilonidal sinus disease (PSD) is common, affecting approximately 26 in 100,000 people. Treatment options and outcomes vary significantly. Chronic symptomatic pilonidal sinus disease primarily affects young adults and leads to substantial work loss. Due to the heterogeneous nature of clinical presentations, finding a single treatment approach for PSD has proven difficult. Future clinical studies might benefit from focusing on the best management strategies rather than the best technique.
Literature indicates that the minimally invasive pit-picking procedure has a general treatment success rate of 68%, with low postoperative complication rates, chronic pain, and high patient satisfaction regarding cosmetic appearance. It is seen as a better option in terms of pain, wound healing time, and complication rates. For simple, uncomplicated pilonidal sinus cases, the pit-picking method is an alternative to flap surgery in terms of wound healing and recurrence.
Particularly for patients with fewer than two pits and no lateral extensions, crystallized phenol application (CPT) is a good alternative to modified Limberg flap surgery and other surgical procedures. CPT, being a minimally invasive procedure performed under local anesthesia, has higher success rates after recurrent applications and shorter hospital stays. Long-term results for CPT treatment are also quite successful. Studies show that in addition to endoscopic pilonidal sinus treatment, crystallized phenol treatment is safe, well-tolerated, and provides quick and lasting recovery without recurrence over the follow-up period.
The presented study aims to compare the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, CPT Application, and Combined Pit Picking and CPT Application. The study will evaluate the short- and long-term results, treatment success, incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the study will examine the effects of these methods on hospital stay, wound healing time, and workforce loss. The presented study aims to determine whether minimally invasive procedures and CPT treatment offer better management strategies for pilonidal sinus disease. The findings are expected to contribute to identifying the most suitable treatment method for pilonidal sinus disease.
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bascom's pit-picking | In the pit-picking technique, midline pits will be excised with minimal tissue removal (skin margin <1 mm). Hairs in the sinuses will be removed along with the curetted tissues. The midline excision areas and secondary pits excised near the midline will be closed with 3-0 polypropylene. | |
| Crystallized phenol | In crystallized phenol treatment, the pit will be expanded with the help of a clamp, and after confirming it is uncomplicated, hair and infected tissue will be cleaned. Nitrofurazone will be applied to the pit edges. Crystallized phenol will be filled into the sinus with the help of a clamp. | |
| Combined treatment | In the combined treatment, crystallized phenol will be applied after pit picking, and the pit area will be left to secondary healing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing.
Measured: Up to 12 months post-treatment
Postoperative Complications
This measure will assess the incidence of postoperative complications such as infection and pain.
Measured: Up to 3 months post-treatment.
Secondary outcomes (3)
Recurrence Rate
Evaluation of the rate of disease recurrence after treatment.
Measured: Up to 12 months post-treatment
Chronic Pain Level
Assessment of chronic pain levels in patients following treatment using the Visual Analog Scale (VAS). VAS is a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.
Measured: Up to 3 months post-treatment
Patient Satisfaction
Measurement of patient satisfaction with the treatment process and outcomes using the Patient and Observer Scar Assessment Scale (POSAS). POSAS is a scale from 1 to 10, where 1 represents the best outcome and 10 represents the worst outcome. Higher scores indicate worse outcomes.
Measured: Up to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517472
- Sponsor's protocol ID
- Ivstrh 214
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
- ClinicalTrials.gov ID
- NCT06517472
- Acronym / sponsor ID
- Ivstrh 214
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Jul 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 sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.
Detailed description
Pilonidal sinus disease (PSD) is common, affecting approximately 26 in 100,000 people. Treatment options and outcomes vary significantly. Chronic symptomatic pilonidal sinus disease primarily affects young adults and leads to substantial work loss. Due to the heterogeneous nature of clinical presentations, finding a single treatment approach for PSD has proven difficult. Future clinical studies might benefit from focusing on the best management strategies rather than the best technique.
Literature indicates that the minimally invasive pit-picking procedure has a general treatment success rate of 68%, with low postoperative complication rates, chronic pain, and high patient satisfaction regarding cosmetic appearance. It is seen as a better option in terms of pain, wound healing time, and complication rates. For simple, uncomplicated pilonidal sinus cases, the pit-picking method is an alternative to flap surgery in terms of wound healing and recurrence.
Particularly for patients with fewer than two pits and no lateral extensions, crystallized phenol application (CPT) is a good alternative to modified Limberg flap surgery and other surgical procedures. CPT, being a minimally invasive procedure performed under local anesthesia, has higher success rates after recurrent applications and shorter hospital stays. Long-term results for CPT treatment are also quite successful. Studies show that in addition to endoscopic pilonidal sinus treatment, crystallized phenol treatment is safe, well-tolerated, and provides quick and lasting recovery without recurrence over the follow-up period.
The presented study aims to compare the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, CPT Application, and Combined Pit Picking and CPT Application. The study will evaluate the short- and long-term results, treatment success, incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the study will examine the effects of these methods on hospital stay, wound healing time, and workforce loss. The presented study aims to determine whether minimally invasive procedures and CPT treatment offer better management strategies for pilonidal sinus disease. The findings are expected to contribute to identifying the most suitable treatment method for pilonidal sinus disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bascom's pit-picking | – | –In the pit-picking technique, midline pits will be excised with minimal tissue removal (skin margin <1 mm). Hairs in the sinuses will be removed along with the curetted tissues. The midline excision areas and secondary pits excised near the midline will be closed with 3-0 polypropylene. |
| Crystallized phenol | – | –In crystallized phenol treatment, the pit will be expanded with the help of a clamp, and after confirming it is uncomplicated, hair and infected tissue will be cleaned. Nitrofurazone will be applied to the pit edges. Crystallized phenol will be filled into the sinus with the help of a clamp. |
| Combined treatment | – | –In the combined treatment, crystallized phenol will be applied after pit picking, and the pit area will be left to secondary healing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18 and older with pilonidal sinus disease and two or fewer pits, with no previous surgical treatment.
Key inclusion criteria (1 listed)
- Having two pits or less
Key exclusion criteria (5 listed)
- With bilateral lateral extension,
- Stage-R with recurrent disease
- Number of pits more than three pits,
- Collagen tissue disease,
- Patients with a postoperative follow-up period of less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Success
Time frame: Up to 12 months post-treatment
The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing.
Postoperative Complications
Time frame: Up to 3 months post-treatment.
This measure will assess the incidence of postoperative complications such as infection and pain.
3 secondary outcomes
Recurrence Rate
Time frame: Up to 12 months post-treatment
Chronic Pain Level
Time frame: Up to 3 months post-treatment
Patient Satisfaction
Time frame: Up to 12 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training 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 5 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 8 Oct 2024. 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?
Contact Adnan Gundogdu (+905367173909, adnangundogdu89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: Up to 12 months post-treatment). The study lists 2 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 8 Oct 2024.