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

NCT07420452 | Not Yet Recruiting

• 1 other identifier: PNS-RCT-2026-SILPHEN
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pilonidal Sinus Disease

Keywords

Pilonidal Sinus Disease; SiLac; Phenol; Sacrococcygeal Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month

Secondary Outcomes (7)

• Postoperative Pain (VAS Score)

  Postoperative day 1 and week 1

• Postoperative Analgesic Consumption

  Within the first postoperative week

• Wound Healing Time

  Up to 6 months

• Wound-Related Complications

  Within 6 months after treatment

• Time to Return to Work

  Within 6 months after treatment

Study Arms (2)

SiLAc Group

EXPERIMENTAL

Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease.

Procedure: SiLac (Laser Ablation)

Phenol Group

EXPERIMENTAL

Participants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease.

Procedure: Phenol Application

Interventions

SiLac (Laser Ablation) PROCEDURE

Laser ablation of the pilonidal sinus tract performed according to the study protocol.

Also known as: SiLac

SiLAc Group

Phenol Application PROCEDURE

Chemical ablation with phenol performed according to the study protocol.

Also known as: Phenol

Phenol Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, İzmir, 35540, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laser Therapy; Phenol

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Mehmet A Ugur

CONTACT

+905345839945; mehmet.alperen.ugur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, General Surgeon

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)