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NCT Number: NCT07420452

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

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.

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Key information

Conditions

Pilonidal Sinus Disease

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SiLac (Laser Ablation)

Procedure

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

Other names: SiLac

Phenol Application

Procedure

Chemical ablation with phenol performed according to the study protocol.

Other names: Phenol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. Wound Healing Time

    Time frame: Up to 6 months

    Time required for complete epithelialization of the treated area without discharge.

  4. 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.

  5. 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.

  6. Patient Satisfaction

    Time frame: At 6 months after treatment

    Patient-reported satisfaction with treatment outcome assessed using a standardized satisfaction scale.

  7. Treatment Cost

    Time frame: During the 6-month follow-up period

    Direct medical costs associated with each treatment method.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet A Ugur

CONTACT

[email protected]

+905345839945

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

Comparison of Silac and Phenol Treatments in Primary Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial With 6-Month Follow-up

Acronym: SILPHEN26

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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