LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE

NCT07701772 | Not Yet Recruiting

• 1 other identifier: SEAH-PİSİ
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Secondary objectives include complete epithelialization by day 30, time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and 6-month recurrence.

Conditions

Sacrococcygeal Pilonidal Sinus Disease; Pilonidal Sinus Disease

Keywords

Pilonidal sinus disease; Laser ablation; Crystallized phenol; Randomized trial; Postoperative pain; Recurrence; Complete epithelialization

Outcome Measures

Primary Outcomes (1)

• Postoperative day 1 pain score

  Pain intensity on postoperative day 1 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.

  Postoperative day 1

Secondary Outcomes (8)

• Complete epithelialization at day 30

  Postoperative day 30

• Time to complete epithelialization

  Up to 30 days

• Postoperative day 7 pain score

  Postoperative day 7

• Duration of analgesic use

  Up to 30 days

• Time to return to daily activities

  Up to 30 days

Study Arms (2)

Laser ablation

EXPERIMENTAL

Participants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser.

Procedure: Laser Ablation

Crystallized phenol

ACTIVE COMPARATOR

Participants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity.

Procedure: Crystallized phenol application

Interventions

Laser Ablation PROCEDURE

After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser.

Laser ablation

Crystallized phenol application PROCEDURE

After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.

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 or older
• Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
• Uncomplicated disease
• Suitability for minimally invasive treatment
• Provision of written informed consent

You may not qualify if:

• Acute pilonidal abscess
• History of pilonidal abscess drainage
• Previous surgical or interventional treatment for pilonidal sinus disease
• Recurrent pilonidal disease
• Complex pilonidal disease or marked lateral extension
• Immunosuppression, chronic steroid use, or systemic conditions that may significantly impair wound healing
• Inability to attend regular follow-up
• Refusal to participate in the study

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Recurrence

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Vedat Kaplan

CONTACT

+905459045165; vedat_kaplan_@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized in a 1:1 ratio to either laser ablation or crystallized phenol treatment in a parallel-group design.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share