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Active, not recruiting Observational

Laser and Phenol Treatment for Pilonidal Sinus

NCT07022899 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-01-25
Last updated
2025-06-15

Condition(s) studied

Pilonidal Sinus Treatment

Study summary

This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients.

Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. It happens when hair gets trapped under the skin, causing pain, swelling, and infection. This condition mainly affects young adults and can interfere with work and daily activities.

The study compares three minimally invasive treatments:

1. Laser therapy alone: A thin laser fiber is inserted into the sinus to destroy the lining and close the tunnel using local anesthesia as an outpatient procedure.
2. Phenol treatment alone: A chemical solution (phenol) is injected into the sinus to make it close and heal, done with local anesthesia in the clinic.
3. Combined laser and phenol therapy: Both treatments are used together for potentially better healing with lower recurrence rates.

Researchers will measure healing rates, healing time, recurrence rates, pain levels, complications, patient satisfaction, and return to normal activities.

This research is important because there is no single "best" treatment for pilonidal sinus. Traditional surgery often requires general anesthesia, hospital stays, large wounds taking months to heal, significant scarring, long work absence, and high recurrence rates up to 30%.

These newer treatments offer faster healing, less pain and scarring, quicker return to normal life, and lower recurrence chance. By comparing these approaches directly, this study will help doctors and patients make better treatment decisions based on scientific evidence.

This is a prospective observational cohort study following patients who receive one of these three treatments. The study will include adults with pilonidal sinus disease suitable for minimally invasive treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years and older * Diagnosed chronic pilonidal sinus disease confirmed by clinical examination * Suitable for minimally invasive treatment approaches * Ability to provide informed consent * Willingness to comply with follow-up schedule * No contraindications to local anesthesia Exclusion Criteria: * Active acute pilonidal abscess requiring emergency drainage * Previous pilonidal sinus surgery or treatment * Pregnancy or breastfeeding * Immunocompromised patients (diabetes mellitus, immunosuppressive therapy, chronic corticosteroid use) * Malignancy in the sacrococcygeal region * Bleeding disorders or anticoagulant therapy that cannot be discontinued * Allergy to local anesthetics (lidocaine) * Mental incapacity or psychiatric illness preventing informed consent * Geographic inaccessibility for follow-up visits

Primary outcome measure(s)

  • Complete Healing Rate — 6 months
    Complete Healing Rate
  • Recurrence Rate — 12 months
    Percentage of patients experiencing recurrence of pilonidal sinus disease defined as reappearance of symptoms, discharge, or new sinus formation at the treatment site

Trial sites (1)

FacilityCityRegionStatus
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07022899 on ClinicalTrials.gov ↗ ← All trials in Turkey