Adding phenol to laser treatment for pilonidal sinus healing
Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus: A Prospective Randomized Controlled Clinical Trial
NA · Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · NCT07023952
This will see if adding crystallized phenol to a day-surgery laser treatment helps adults with primary pilonidal sinus heal faster and return to normal activities sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital (other) |
| Locations | 1 site (Istanbul, Other) |
| Trial ID | NCT07023952 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized trial that will assign 130 adults with primary pilonidal sinus to either SiLaC laser treatment alone or crystallized phenol followed by SiLaC. Both procedures are performed under local anesthesia as same-day, minimally invasive treatments. Outcomes include time to epithelialization, pain (VAS), return to daily activities, and quality of life (SF-36) with follow-up at 2 weeks, 4 weeks, and 3 months. Statistical comparisons will be made between the two groups to determine whether phenol adds benefit to laser closure.
Who should consider this trial
Good fit: Adults aged 18 or older with primary pilonidal sinus disease, three or fewer pits, no acute abscess or bilateral lateral extension, and who can attend follow-up visits are the intended participants.
Not a fit: Patients with recurrent disease, more than three pits, acute abscess, bilateral extension, immunocompromise, pregnancy, or severe comorbidities are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding phenol could shorten healing time, reduce pain, and speed patients' return to work and daily life.
How similar studies have performed: Previous research supports SiLaC (laser) and phenol as effective minimally invasive options separately, but randomized data on the combined phenol-plus-laser approach are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Other
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul, Other, Turkey (Türkiye) (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pilonidal Sinus Disease, Laser Therapy, Minimally Invasive Treatment, Day Surgery