Pilonidal Sinus TreatmentNCT07022899
Laser and Phenol Treatment for Pilonidal Sinus
An observational study of Pilonidal Sinus Treatment, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients. Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 25 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients with chronic pilonidal sinus disease seeking treatment at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery.
Who may be able to join
- Age 18 years and older
- Diagnosed chronic pilonidal sinus disease confirmed by clinical examination
- Suitable for minimally invasive treatment approaches
- Ability to provide informed consent
- Willingness to comply with follow-up schedule
- No contraindications to local anesthesia
Who cannot join
- Active acute pilonidal abscess requiring emergency drainage
- Previous pilonidal sinus surgery or treatment
- Pregnancy or breastfeeding
- Immunocompromised patients (diabetes mellitus, immunosuppressive therapy, chronic corticosteroid use)
- Malignancy in the sacrococcygeal region
- Bleeding disorders or anticoagulant therapy that cannot be discontinued
Show all 9Show fewer
- Allergy to local anesthetics (lidocaine)
- Mental incapacity or psychiatric illness preventing informed consent
- Geographic inaccessibility for follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, 34785
About this study
Official title: Laser and Phenol Treatment for Pilonidal Sinus: Outcomes of Monotherapy and Combined Approach
This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients.
Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. It happens when hair gets trapped under the skin, causing pain, swelling, and infection. This condition mainly affects young adults and can interfere with work and daily activities.
Read more
The study compares three minimally invasive treatments:
- Laser therapy alone: A thin laser fiber is inserted into the sinus to destroy the lining and close the tunnel using local anesthesia as an outpatient procedure.
- Phenol treatment alone: A chemical solution (phenol) is injected into the sinus to make it close and heal, done with local anesthesia in the clinic.
- Combined laser and phenol therapy: Both treatments are used together for potentially better healing with lower recurrence rates.
Researchers will measure healing rates, healing time, recurrence rates, pain levels, complications, patient satisfaction, and return to normal activities.
This research is important because there is no single "best" treatment for pilonidal sinus. Traditional surgery often requires general anesthesia, hospital stays, large wounds taking months to heal, significant scarring, long work absence, and high recurrence rates up to 30%.
These newer treatments offer faster healing, less pain and scarring, quicker return to normal life, and lower recurrence chance. By comparing these approaches directly, this study will help doctors and patients make better treatment decisions based on scientific evidence.
This is a prospective observational cohort study following patients who receive one of these three treatments. The study will include adults with pilonidal sinus disease suitable for minimally invasive treatment.
Read the detailed description
Detailed Description şu şekilde olmalı (sample size dahil):
STUDY DESIGN AND METHODOLOGY
This prospective observational cohort study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery. The study aims to compare the clinical outcomes of three different minimally invasive treatment approaches for pilonidal sinus disease.
TREATMENT GROUPS
Group 1 - Laser Therapy: Patients will receive diode laser treatment using a radial fiber inserted into the pilonidal sinus tract. The procedure is performed under local anesthesia with lidocaine injection.
Group 2 - Phenol Treatment: Patients will receive crystallized phenol application into the sinus cavity after debridement of hair and debris. The procedure is performed under local anesthesia.
Group 3 - Combined Treatment: Patients will receive both laser therapy followed by phenol application in the same session under local anesthesia.
SAMPLE SIZE
This is a pilot comparative study designed to evaluate the feasibility and preliminary efficacy of three treatment approaches. Sample size will be determined based on patient availability and recruitment capacity during the study period. All eligible patients meeting inclusion criteria will be enrolled consecutively.
FOLLOW-UP SCHEDULE
Patients will be evaluated at 1 week, 1 month, 3 months, 6 months, and 12 months post-treatment.
PRIMARY ENDPOINTS
- Complete healing rate (absence of discharge, pain, and complete epithelialization)
- Recurrence rate at 12 months
SECONDARY ENDPOINTS
- Time to complete healing
- Post-operative pain scores (VAS)
- Complication rates
- Patient satisfaction scores
- Return to normal activities
- Quality of life assessment
STATISTICAL ANALYSIS
Categorical variables will be analyzed using Chi-square test. Continuous variables will be analyzed using appropriate parametric or non-parametric tests. Kaplan-Meier survival analysis will be used for time-to-healing assessment.
- Conditions
- Pilonidal Sinus Treatment
- Keywords
- Pilonidal Cyst Pilonidal Abscess Sacrococcygeal 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 |
|---|---|---|
| Laser Therapy Group Group Type: Other | Patients receiving diode laser treatment alone for pilonidal sinus disease | |
| Phenol Treatment Group | Patients receiving crystallized phenol application alone for pilonidal sinus disease | |
| Combined Treatment Group | Patients receiving both laser therapy and phenol treatment in combination for pilonidal sinus disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Healing Rate
Complete Healing Rate
Measured: 6 months
Recurrence Rate
Percentage of patients experiencing recurrence of pilonidal sinus disease defined as reappearance of symptoms, discharge, or new sinus formation at the treatment site
Measured: 12 months
Secondary outcomes (3)
Time to Complete Healing
Time in weeks from treatment to complete healing
Measured: Up to 12 months
Post-operative Pain Score
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0-10
Measured: 1 week, 1 month, 3 months
Complication Rate
Percentage of patients experiencing treatment-related complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start25 Jan 2025
- Primary completion2 Jun 2025
- Study completion25 Jun 2026 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Gundogdu, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022899
- Sponsor's protocol ID
- Ivstrh_pilonidal
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient privacy protection requirements under Turkish data protection laws and the small sample size of this single-center study. Study results will be shared through scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser and Phenol Treatment for Pilonidal Sinus: Outcomes of Monotherapy and Combined Approach
- ClinicalTrials.gov ID
- NCT07022899
- Acronym / sponsor ID
- Ivstrh_pilonidal
- Conditions
- Pilonidal Sinus Treatment
- Keywords
- Pilonidal Cyst Pilonidal Abscess Sacrococcygeal Pilonidal Sinus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients.
Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. It happens when hair gets trapped under the skin, causing pain, swelling, and infection. This condition mainly affects young adults and can interfere with work and daily activities.
The study compares three minimally invasive treatments:
- Laser therapy alone: A thin laser fiber is inserted into the sinus to destroy the lining and close the tunnel using local anesthesia as an outpatient procedure.
- Phenol treatment alone: A chemical solution (phenol) is injected into the sinus to make it close and heal, done with local anesthesia in the clinic.
- Combined laser and phenol therapy: Both treatments are used together for potentially better healing with lower recurrence rates.
Researchers will measure healing rates, healing time, recurrence rates, pain levels, complications, patient satisfaction, and return to normal activities.
This research is important because there is no single "best" treatment for pilonidal sinus. Traditional surgery often requires general anesthesia, hospital stays, large wounds taking months to heal, significant scarring, long work absence, and high recurrence rates up to 30%.
These newer treatments offer faster healing, less pain and scarring, quicker return to normal life, and lower recurrence chance. By comparing these approaches directly, this study will help doctors and patients make better treatment decisions based on scientific evidence.
This is a prospective observational cohort study following patients who receive one of these three treatments. The study will include adults with pilonidal sinus disease suitable for minimally invasive treatment.
Detailed description
Detailed Description şu şekilde olmalı (sample size dahil):
STUDY DESIGN AND METHODOLOGY
This prospective observational cohort study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery. The study aims to compare the clinical outcomes of three different minimally invasive treatment approaches for pilonidal sinus disease.
TREATMENT GROUPS
Group 1 - Laser Therapy: Patients will receive diode laser treatment using a radial fiber inserted into the pilonidal sinus tract. The procedure is performed under local anesthesia with lidocaine injection.
Group 2 - Phenol Treatment: Patients will receive crystallized phenol application into the sinus cavity after debridement of hair and debris. The procedure is performed under local anesthesia.
Group 3 - Combined Treatment: Patients will receive both laser therapy followed by phenol application in the same session under local anesthesia.
SAMPLE SIZE
This is a pilot comparative study designed to evaluate the feasibility and preliminary efficacy of three treatment approaches. Sample size will be determined based on patient availability and recruitment capacity during the study period. All eligible patients meeting inclusion criteria will be enrolled consecutively.
FOLLOW-UP SCHEDULE
Patients will be evaluated at 1 week, 1 month, 3 months, 6 months, and 12 months post-treatment.
PRIMARY ENDPOINTS
- Complete healing rate (absence of discharge, pain, and complete epithelialization)
- Recurrence rate at 12 months
SECONDARY ENDPOINTS
- Time to complete healing
- Post-operative pain scores (VAS)
- Complication rates
- Patient satisfaction scores
- Return to normal activities
- Quality of life assessment
STATISTICAL ANALYSIS
Categorical variables will be analyzed using Chi-square test. Continuous variables will be analyzed using appropriate parametric or non-parametric tests. Kaplan-Meier survival analysis will be used for time-to-healing assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy Group Group Type: Other | – | –Patients receiving diode laser treatment alone for pilonidal sinus disease |
| Phenol Treatment Group | – | –Patients receiving crystallized phenol application alone for pilonidal sinus disease |
| Combined Treatment Group | – | –Patients receiving both laser therapy and phenol treatment in combination for pilonidal sinus disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic pilonidal sinus disease seeking treatment at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery.
Key inclusion criteria (6 listed)
- Age 18 years and older
- Diagnosed chronic pilonidal sinus disease confirmed by clinical examination
- Suitable for minimally invasive treatment approaches
- Ability to provide informed consent
- Willingness to comply with follow-up schedule
Key exclusion criteria (9 listed)
- Active acute pilonidal abscess requiring emergency drainage
- Previous pilonidal sinus surgery or treatment
- Pregnancy or breastfeeding
- Immunocompromised patients (diabetes mellitus, immunosuppressive therapy, chronic corticosteroid use)
- Malignancy in the sacrococcygeal region
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
Complete Healing Rate
Time frame: 6 months
Complete Healing Rate
Recurrence Rate
Time frame: 12 months
Percentage of patients experiencing recurrence of pilonidal sinus disease defined as reappearance of symptoms, discharge, or new sinus formation at the treatment site
3 secondary outcomes
Time to Complete Healing
Time frame: Up to 12 months
Post-operative Pain Score
Time frame: 1 week, 1 month, 3 months
Complication Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient privacy protection requirements under Turkish data protection laws and the small sample size of this single-center study. Study results will be shared through scientific publications.
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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?
An observational study of Pilonidal Sinus Treatment, 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Complete Healing Rate (time frame: 6 months). 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 15 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.