Pilonidal Sinus DiseaseSILPHEN26NCT07420452
Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial
A study testing SiLac (Laser Ablation) and Phenol Application in people with Pilonidal Sinus Disease, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pilonidal Sinus Disease
- What is being tested?
- SiLac (Laser Ablation) and Phenol Application
- 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
- 12 Feb 2026to 31 Dec 2026
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 64 years
- Diagnosis of primary pilonidal sinus disease
- Maximum of three sinus openings (pits)
- History of no more than two previous abscess episodes
- Ability to provide written informed consent
Who cannot join
- Recurrent or previously operated pilonidal sinus disease
- More than three sinus openings
- More than two previous abscess episodes
- Acute abscess requiring emergency drainage at presentation
- Presence of significant uncontrolled comorbidities
- Pregnancy
- Inability to comply with follow-up
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
Izmir City Hospital
Izmir, İzmir, 35540
Mehmet A Ugur, +905345839945, mehmet.alperen.ugur@gmail.com
Halil Yıldız, +905416572995, drhalilyildiz@gmail.com
About this study
Official title: Comparison of Silac and Phenol Treatments in Primary Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial With 6-Month Follow-up
Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques.
The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost.
Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.
Read the detailed description
Pilonidal sinus disease (PSD) is a chronic inflammatory condition commonly affecting young adults and is associated with significant morbidity, including pain, recurrent infections, and impaired quality of life. Minimally invasive treatment approaches have gained popularity in recent years in order to reduce postoperative pain, shorten recovery time, and lower recurrence rates compared to conventional excisional surgery.
Silac (laser ablation of the sinus tract) and phenol application are two minimally invasive techniques currently used in the management of primary pilonidal sinus disease. Although both methods are widely practiced, high-quality comparative evidence regarding their relative effectiveness remains limited.
This prospective randomized controlled trial aims to compare Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients aged 18-64 years with primary disease, a maximum of three pits, and no more than two prior abscess episodes will be included. Patients with recurrent or secondary disease and significant comorbidities will be excluded.
Participants will be randomly allocated in a 1:1 ratio to receive either Silac or phenol treatment. The primary outcome measure is recurrence rate during follow-up. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), wound healing time, time to return to work, patient satisfaction, and cost analysis.
Patient recruitment will be conducted over a 6-month period. Each participant will be followed for 6 months after treatment, resulting in a total study duration of 12 months. Statistical analysis will be performed to compare outcomes between groups, with significance set at p < 0.05.
- Conditions
- Pilonidal Sinus Disease
- Being tested
- SiLac (Laser Ablation), Phenol Application
- Keywords
- Pilonidal Sinus Disease, SiLac, Phenol, Sacrococcygeal Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiLac (Laser Ablation)Procedure or surgery
Also called SiLac
Laser ablation of the pilonidal sinus tract performed according to the study protocol.
Phenol ApplicationProcedure or surgery
Also called Phenol
Chemical ablation with phenol performed according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| SiLAc Group | Experimental | Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease. Receives: Procedure: SiLac (Laser Ablation) |
| Phenol Group | Experimental | Participants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease. Receives: Procedure: Phenol Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up.
Measured: 6 month
Secondary outcomes (7)
Postoperative Pain (VAS Score)
Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Postoperative day 1 and week 1
Postoperative Analgesic Consumption
Use of analgesic medication after treatment, measured as the proportion of patients requiring analgesics and/or the total number of analgesic doses used during the early postoperative period.
Measured: Within the first postoperative week
Wound Healing Time
Time required for complete epithelialization of the treated area without discharge.
Measured: Up to 6 months
Wound-Related Complications
Occurrence of wound-related complications, including infection, abscess formation, cellulitis, seroma/hematoma, prolonged discharge (>30 days), or need for additional medical or surgical intervention. Early (≤30 days) and late (>30 days to 6 months) complications will be recorded separately.
Measured: Within 6 months after treatment
Time to Return to Work
Number of days from treatment to return to normal daily activities or work.
Measured: Within 6 months after treatment
Patient Satisfaction
Patient-reported satisfaction with treatment outcome assessed using a standardized satisfaction scale.
Measured: At 6 months after treatment
Treatment Cost
Direct medical costs associated with each treatment method.
Measured: During the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Alperen Uğur, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420452
- Sponsor's protocol ID
- PNS-RCT-2026-SILPHEN
- Acronym
- SILPHEN26
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Silac and Phenol Treatments in Primary Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial With 6-Month Follow-up
- ClinicalTrials.gov ID
- NCT07420452
- Acronym / sponsor ID
- SILPHEN26 / PNS-RCT-2026-SILPHEN
- Conditions
- Pilonidal Sinus Disease
- Keywords
- Pilonidal Sinus Disease, SiLac, Phenol, Sacrococcygeal Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (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 affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques.
The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost.
Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.
Detailed description
Pilonidal sinus disease (PSD) is a chronic inflammatory condition commonly affecting young adults and is associated with significant morbidity, including pain, recurrent infections, and impaired quality of life. Minimally invasive treatment approaches have gained popularity in recent years in order to reduce postoperative pain, shorten recovery time, and lower recurrence rates compared to conventional excisional surgery.
Silac (laser ablation of the sinus tract) and phenol application are two minimally invasive techniques currently used in the management of primary pilonidal sinus disease. Although both methods are widely practiced, high-quality comparative evidence regarding their relative effectiveness remains limited.
This prospective randomized controlled trial aims to compare Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients aged 18-64 years with primary disease, a maximum of three pits, and no more than two prior abscess episodes will be included. Patients with recurrent or secondary disease and significant comorbidities will be excluded.
Participants will be randomly allocated in a 1:1 ratio to receive either Silac or phenol treatment. The primary outcome measure is recurrence rate during follow-up. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), wound healing time, time to return to work, patient satisfaction, and cost analysis.
Patient recruitment will be conducted over a 6-month period. Each participant will be followed for 6 months after treatment, resulting in a total study duration of 12 months. Statistical analysis will be performed to compare outcomes between groups, with significance set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SiLAc Group | Experimental | Procedure: SiLac (Laser Ablation)Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease. |
| Phenol Group | Experimental | Procedure: Phenol ApplicationParticipants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 64 years
- Diagnosis of primary pilonidal sinus disease
- Maximum of three sinus openings (pits)
- History of no more than two previous abscess episodes
- Ability to provide written informed consent
Key exclusion criteria (7 listed)
- Recurrent or previously operated pilonidal sinus disease
- More than three sinus openings
- More than two previous abscess episodes
- Acute abscess requiring emergency drainage at presentation
- Presence of significant uncontrolled comorbidities
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 |
|---|---|---|
| SiLac (Laser Ablation)Also: SiLacLaser ablation of the pilonidal sinus tract performed according to the study protocol. | Procedure or surgery | SiLAc Group |
| Phenol ApplicationAlso: PhenolChemical ablation with phenol performed according to the study protocol. | Procedure or surgery | Phenol Group |
Primary outcome
Recurrence Rate
Time frame: 6 month
Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up.
7 secondary outcomes
Postoperative Pain (VAS Score)
Time frame: Postoperative day 1 and week 1
Postoperative Analgesic Consumption
Time frame: Within the first postoperative week
Wound Healing Time
Time frame: Up to 6 months
Wound-Related Complications
Time frame: Within 6 months after treatment
Time to Return to Work
Time frame: Within 6 months after treatment
Patient Satisfaction
Time frame: At 6 months after treatment
Treatment Cost
Time frame: During the 6-month follow-up period
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 19 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SiLac (Laser Ablation) and Phenol Application in people with Pilonidal Sinus Disease, run by Izmir City 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 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: opening soon, as of the sponsor's last update on 19 Feb 2026. 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?
Contact Mehmet A Ugur (+905345839945, mehmet.alperen.ugur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate (time frame: 6 month). 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 19 Feb 2026.