Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus

NCT07023952 | Recruiting

• 1 other identifier: PSL-FENOL-2025-001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work. Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures. The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period. This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.

Conditions

Pilonidal Sinus Disease; Laser Therapy

Keywords

Minimally Invasive Treatment; Day Surgery

Outcome Measures

Primary Outcomes (1)

• Time to Complete Epithelialization

  Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area.

  From date of surgery until complete epithelialization is achieved, assessed up to 3 months

Secondary Outcomes (4)

• Postoperative Pain Scores

  Measured at 2 weeks, 4 weeks, and 3 months post-surgery

• Return to Daily Activities Time

  From date of surgery until return to normal activities, assessed up to 3 months

• Complication Rate

  From surgery through 3 months follow-up

• Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction

  At 3 months post-surgery

Study Arms (2)

Laser Treatment Only

ACTIVE COMPARATOR

Participants receive laser treatment (SiLaC - Sinus Laser Closure) under local anesthesia. The pilonidal sinus area is cleaned, sinus openings are evaluated, and laser probe is inserted into sinus channels for ablation. Standard post-operative wound care is provided with same-day discharge.

Procedure: Laser Treatment

Crystallized Phenol

EXPERIMENTAL

Participants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge.

Procedure: Laser Treatment; Drug: Crystallized Phenol

Interventions

Laser Treatment PROCEDURE

Minimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity.

Also known as: Pilonidal Sinus Laser Ablation

Crystallized Phenol; Laser Treatment Only

Crystallized Phenol DRUG

rystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation.

Also known as: Phenol Crystals

Crystallized Phenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Primary pilonidal sinus disease
• Three or fewer pit counts
• Willing to participate in the study and signed informed consent form
• Able to attend follow-up visits

You may not qualify if:

• Age under 18 years
• More than three pit counts
• Acute abscess presentation
• Bilateral lateral extension
• Recurrent pilonidal sinus disease
• Immunocompromised patients
• Patients unable to attend follow-up visits
• Pregnancy (if applicable)
• Severe comorbidities that contraindicate surgery under local anesthesia

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul, Other, 34785, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study due to the nature of surgical interventions which cannot be blinded to participants or care providers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups: Group A receives laser treatment only, Group B receives combined phenol and laser treatment

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 17, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)