An interventional study of SiLac (Laser Ablation) and Phenol Application in Pilonidal Sinus Disease, sponsored by Izmir City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Izmir City Hospital · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Izmir City Hospital is the lead sponsor of 25 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease.
Procedure: SiLac (Laser Ablation)
Participants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease.
Procedure: Phenol Application
Laser ablation of the pilonidal sinus tract performed according to the study protocol.
Also known as: SiLac
Chemical ablation with phenol performed according to the study protocol.
Also known as: Phenol
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.
Time frame: 6 month
Postoperative Pain (VAS Score)
Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: 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.
Time frame: Within the first postoperative week
Wound Healing Time
Time required for complete epithelialization of the treated area without discharge.
Time frame: 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.
Time frame: Within 6 months after treatment
Time to Return to Work
Number of days from treatment to return to normal daily activities or work.
Time frame: Within 6 months after treatment
Patient Satisfaction
Patient-reported satisfaction with treatment outcome assessed using a standardized satisfaction scale.
Time frame: At 6 months after treatment
Treatment Cost
Direct medical costs associated with each treatment method.
Time frame: During the 6-month follow-up period
Plan to share: No — Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 4 months is below that.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Izmir City Hospital