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NCT Number: NCT07701772

LASER VERSUS CRYSTALLIZED PHENOL IN 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.

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Key information

Conditions

Sacrococcygeal Pilonidal Sinus Disease Disease Attributes Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pilonidal Sinus Disease Postoperative Complications Recurrence Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Crystallized phenol application

Procedure

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

Primary outcomes

  1. Postoperative day 1 pain score

    Time frame: Postoperative day 1

    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.

Secondary outcomes

  1. Complete epithelialization at day 30

    Time frame: Postoperative day 30

    Presence or absence of complete epithelialization of the wound at postoperative day 30.

  2. Time to complete epithelialization

    Time frame: Up to 30 days

    Time from treatment to complete epithelialization, measured in days.

  3. Postoperative day 7 pain score

    Time frame: Postoperative day 7

    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.

  4. Duration of analgesic use

    Time frame: Up to 30 days

    Duration of postoperative analgesic use, measured in days.

  5. Time to return to daily activities

    Time frame: Up to 30 days

    Time required to return to normal daily activities, measured in days.

  6. Time to return to work

    Time frame: Up to 30 days

    Time required to return to work, measured in days.

  7. Incidence of early local complications

    Time frame: Within 30 days after treatment

    Number and proportion of participants who develop any early local postoperative complication.

  8. Recurrence at 6 months

    Time frame: 6 months

    Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Vedat Kaplan

CONTACT

[email protected]

+905459045165

Sponsors and collaborators

Lead sponsor

Sanliurfa Education and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: PSD-L-F

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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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