Pilonidal Sinus DiseasePLEPSNCT07023952
Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus
A study testing Laser Treatment and Crystallized Phenol in people with Pilonidal Sinus Disease and Laser Therapy, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Disease, Laser Therapy
- What is being tested?
- Laser Treatment and Crystallized Phenol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years and older
- Primary pilonidal sinus disease
- Three or fewer pit counts
- Willing to participate in the study and signed informed consent form
- Able to attend follow-up visits
Who cannot join
- Age under 18 years
- More than three pit counts
- Acute abscess presentation
- Bilateral lateral extension
- Recurrent pilonidal sinus disease
- Immunocompromised patients
Show all 9Show fewer
- Patients unable to attend follow-up visits
- Pregnancy (if applicable)
- Severe comorbidities that contraindicate surgery under local anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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
Official title: Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus: A Prospective Randomized Controlled Clinical Trial
This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work.
Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures.
Read more
The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period.
This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.
Read the detailed description
This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.
Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each):
Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment
Treatment Procedures:
Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels.
Group B receives local anesthesia, sinus area cleaning and curettage, crystallized phenol application into sinus channels, neutralization with saline after a specified time, followed by laser treatment.
Both groups receive standard post-operative wound care instructions and same-day discharge.
Follow-up Schedule:
Preoperative assessment Postoperative visits at 2 weeks, 4 weeks, and 3 months Clinical examination for epithelialization status Pain assessment using Visual Analog Scale (VAS 0-10) Quality of life evaluation using SF-36 questionnaire
Statistical Analysis: R software will be used for statistical analysis. Student's t-test or Mann-Whitney U test for continuous variables, chi-square test for categorical variables, and paired t-test for pre/post-treatment comparisons. Statistical significance set at p<0.05.
Primary Outcome: Time to complete epithelialization Secondary Outcomes: Postoperative pain scores, return to daily activities time, patient satisfaction, quality of life scores, and complication rates.
- Conditions
- Pilonidal Sinus Disease, Laser Therapy
- Being tested
- Laser Treatment, Crystallized Phenol
- Keywords
- Minimally Invasive Treatment, Day Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TreatmentProcedure or surgery
Also called Pilonidal Sinus Laser Ablation
Minimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity.
Crystallized PhenolDrug
Also called Phenol Crystals
rystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment Only | Active comparator | Participants receive laser treatment (SiLaC - Sinus Laser Closure) under local anesthesia. The pilonidal sinus area is cleaned, sinus openings are evaluated, and laser probe is inserted into sinus channels for ablation. Standard post-operative wound care is provided with same-day discharge. Receives: Procedure: Laser Treatment |
| Crystallized Phenol | Experimental | Participants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge. Receives: Procedure: Laser Treatment; Drug: Crystallized Phenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Epithelialization
Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area.
Measured: From date of surgery until complete epithelialization is achieved, assessed up to 3 months
Secondary outcomes (4)
Postoperative Pain Scores
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Measured at 2 weeks, 4 weeks, and 3 months post-surgery
Return to Daily Activities Time
Time required for patients to return to normal daily activities and work, measured in days from surgery
Measured: From date of surgery until return to normal activities, assessed up to 3 months
Complication Rate
Incidence of post-operative complications including infection, wound dehiscence, bleeding, or other adverse events
Measured: From surgery through 3 months follow-up
Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction
Patient satisfaction measured using Visual Analog Scale (VAS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate better satisfaction
Measured: At 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 May 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DiseaseStudies 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
- Model description
- Two parallel groups: Group A receives laser treatment only, Group B receives combined phenol and laser treatment
- Masking
- None (open label)
- Enrolment
- 130 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023952
- Sponsor's protocol ID
- PSL-FENOL-2025-001
- Acronym
- PLEPS
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07023952
- Acronym / sponsor ID
- PLEPS / PSL-FENOL-2025-001
- Conditions
- Pilonidal Sinus Disease, Laser Therapy
- Keywords
- Minimally Invasive Treatment, Day Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 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 two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work.
Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures.
The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period.
This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.
Detailed description
This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.
Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each):
Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment
Treatment Procedures:
Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels.
Group B receives local anesthesia, sinus area cleaning and curettage, crystallized phenol application into sinus channels, neutralization with saline after a specified time, followed by laser treatment.
Both groups receive standard post-operative wound care instructions and same-day discharge.
Follow-up Schedule:
Preoperative assessment Postoperative visits at 2 weeks, 4 weeks, and 3 months Clinical examination for epithelialization status Pain assessment using Visual Analog Scale (VAS 0-10) Quality of life evaluation using SF-36 questionnaire
Statistical Analysis: R software will be used for statistical analysis. Student's t-test or Mann-Whitney U test for continuous variables, chi-square test for categorical variables, and paired t-test for pre/post-treatment comparisons. Statistical significance set at p<0.05.
Primary Outcome: Time to complete epithelialization Secondary Outcomes: Postoperative pain scores, return to daily activities time, patient satisfaction, quality of life scores, and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: Group A receives laser treatment only, Group B receives combined phenol and laser treatment
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment Only | Active comparator | Procedure: Laser TreatmentParticipants receive laser treatment (SiLaC - Sinus Laser Closure) under local anesthesia. The pilonidal sinus area is cleaned, sinus openings are evaluated, and laser probe is inserted into sinus channels for ablation. Standard post-operative wound care is provided with same-day discharge. |
| Crystallized Phenol | Experimental | Procedure: Laser Treatment, Drug: Crystallized PhenolParticipants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older
- Primary pilonidal sinus disease
- Three or fewer pit counts
- Willing to participate in the study and signed informed consent form
- Able to attend follow-up visits
Key exclusion criteria (9 listed)
- Age under 18 years
- More than three pit counts
- Acute abscess presentation
- Bilateral lateral extension
- Recurrent pilonidal sinus disease
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 |
|---|---|---|
| Laser TreatmentAlso: Pilonidal Sinus Laser AblationMinimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity. | Procedure or surgery | Crystallized Phenol, Laser Treatment Only |
| Crystallized PhenolAlso: Phenol Crystalsrystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation. | Drug | Crystallized Phenol |
Primary outcome
Time to Complete Epithelialization
Time frame: From date of surgery until complete epithelialization is achieved, assessed up to 3 months
Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area.
4 secondary outcomes
Postoperative Pain Scores
Time frame: Measured at 2 weeks, 4 weeks, and 3 months post-surgery
Return to Daily Activities Time
Time frame: From date of surgery until return to normal activities, assessed up to 3 months
Complication Rate
Time frame: From surgery through 3 months follow-up
Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction
Time frame: At 3 months post-surgery
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Treatment and Crystallized Phenol in people with Pilonidal Sinus Disease and Laser Therapy, 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 5 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: looking for participants now, as of the sponsor's last update on 17 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Epithelialization (time frame: From date of surgery until complete epithelialization is achieved, assessed up to 3 months). 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 Jun 2025.