Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial (SILPHEN26)

February 12, 2026 updated by: Mehmet Alperen Uğur, Izmir City Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SiLAc Group
Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease.
Procedure: SiLac (Laser Ablation)
Laser ablation of the pilonidal sinus tract performed according to the study protocol.
Other Names:
  • SiLac
Experimental: Phenol Group
Participants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease.
Procedure: Phenol Application
Chemical ablation with phenol performed according to the study protocol.
Other Names:
  • Phenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (VAS Score)
Time Frame: Postoperative day 1 and week 1
Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Postoperative day 1 and week 1
Postoperative Analgesic Consumption
Time Frame: Within the first postoperative week
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.
Within the first postoperative week
Wound Healing Time
Time Frame: Up to 6 months
Time required for complete epithelialization of the treated area without discharge.
Up to 6 months
Wound-Related Complications
Time Frame: Within 6 months after treatment
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.
Within 6 months after treatment
Time to Return to Work
Time Frame: Within 6 months after treatment
Number of days from treatment to return to normal daily activities or work.
Within 6 months after treatment
Patient Satisfaction
Time Frame: At 6 months after treatment
Patient-reported satisfaction with treatment outcome assessed using a standardized satisfaction scale.
At 6 months after treatment
Treatment Cost
Time Frame: During the 6-month follow-up period
Direct medical costs associated with each treatment method.
During the 6-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNS-RCT-2026-SILPHEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pilonidal Sinus Disease

Clinical Trials on SiLac (Laser Ablation)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe