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NCT Number: NCT07023952

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

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.

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Key information

Conditions

Pilonidal Sinus Disease Laser Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Other, 34785, Turkey (Türkiye)

Location status: Recruiting

Location contact

Adnan Gundogdu

CONTACT

[email protected]

+905367173909

About this study

This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.

Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each):

Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment

Treatment Procedures:

Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels.

Group B receives local anesthesia, sinus area cleaning and curettage, crystallized phenol application into sinus channels, neutralization with saline after a specified time, followed by laser treatment.

Both groups receive standard post-operative wound care instructions and same-day discharge.

Follow-up Schedule:

Preoperative assessment Postoperative visits at 2 weeks, 4 weeks, and 3 months Clinical examination for epithelialization status Pain assessment using Visual Analog Scale (VAS 0-10) Quality of life evaluation using SF-36 questionnaire

Statistical Analysis: R software will be used for statistical analysis. Student's t-test or Mann-Whitney U test for continuous variables, chi-square test for categorical variables, and paired t-test for pre/post-treatment comparisons. Statistical significance set at p<0.05.

Primary Outcome: Time to complete epithelialization Secondary Outcomes: Postoperative pain scores, return to daily activities time, patient satisfaction, quality of life scores, and complication rates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Pilonidal Sinus Laser Ablation

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.

Other names: Phenol Crystals

Primary outcomes

  1. Time to Complete Epithelialization

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

    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.

Secondary outcomes

  1. Postoperative Pain Scores

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

    Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable)

  2. Return to Daily Activities Time

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

    Time required for patients to return to normal daily activities and work, measured in days from surgery

  3. Complication Rate

    Time frame: From surgery through 3 months follow-up

    Incidence of post-operative complications including infection, wound dehiscence, bleeding, or other adverse events

  4. Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction

    Time frame: At 3 months post-surgery

    Patient satisfaction measured using Visual Analog Scale (VAS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate better satisfaction

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus: A Prospective Randomized Controlled Clinical Trial

Acronym: PLEPS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

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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