LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE (PSD-L-F)

A PROSPECTIVE RANDOMIZED COMPARISON OF LASER ABLATION AND CRYSTALLIZED PHENOL APPLICATION IN PRIMARY UNCOMPLICATED SACROCOCCYGEAL PILONIDAL SINUS DISEASE

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sacrococcygeal Pilonidal Sinus Disease; Pilonidal Sinus Disease
• Intervention / Treatment: Procedure: Laser Ablation; Procedure: Crystallized phenol application

Detailed Description

This is a single-center, prospective, 1:1 parallel-group randomized clinical trial in adults with primary uncomplicated chronic sacrococcygeal pilonidal sinus disease. A total of 120 participants are planned, with 60 assigned to laser ablation and 60 assigned to crystallized phenol treatment. Randomization will be performed using computer-generated variable blocks, with stratification by pit number and Guner stage when feasible. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. In both groups, a small incision of approximately 1 cm will be made, hair and debris within the sinus cavity will be removed, and curettage will be performed. After these shared preparation steps, the intervention group will receive Leonardo Mini 1470 nm diode laser treatment and the comparison group will receive crystallized phenol application. Repeat sessions with the same assigned treatment may be performed when needed within the secondary healing protocol. The primary endpoint is postoperative day 1 pain intensity measured by Visual Analog Scale. The main secondary endpoint is complete epithelialization at day 30. Other secondary outcomes include time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and recurrence at 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vedat Kaplan; Phone Number: +905459045165; Email: vedat_kaplan_@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser ablation; Participants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser.	Procedure: Laser Ablation; After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser.
Active Comparator: Crystallized phenol; Participants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity.	Procedure: Crystallized phenol application; After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete epithelialization at day 30	Presence or absence of complete epithelialization of the wound at postoperative day 30.	Postoperative day 30
Time to complete epithelialization	Time from treatment to complete epithelialization, measured in days.	Up to 30 days
Postoperative day 7 pain score	Pain intensity on postoperative day 7 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 7
Duration of analgesic use	Duration of postoperative analgesic use, measured in days.	Up to 30 days
Time to return to daily activities	Time required to return to normal daily activities, measured in days.	Up to 30 days
Time to return to work	Time required to return to work, measured in days.	Up to 30 days
Incidence of early local complications	Number and proportion of participants who develop any early local postoperative complication.	Within 30 days after treatment
Recurrence at 6 months	Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment.	6 months

Collaborators and Investigators

• Sponsor: Sanliurfa Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Recurrence; Randomized trial; Postoperative pain; Laser ablation; Pilonidal sinus disease; Crystallized phenol; Complete epithelialization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Recurrence; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Laser Therapy
• Other Study ID Numbers: SEAH-PİSİ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a single-center clinical study involving sensitive patient-level data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No