Actively Recruiting
Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus A Prospective Randomized Controlled Clinical Trial
Led by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Updated on 2025-06-17
130
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatment methods for pilonidal sinus disease, a common condition affecting young adults that causes discomfort and time off work. The study compares laser treatment alone to laser treatment combined with crystallized phenol application to see if adding phenol can speed up healing and improve patient outcomes. This is a prospective randomized controlled clinical trial conducted at a training and research hospital. Participants will be randomly assigned to one of two groups: one receiving laser treatment only using the SiLaC (Sinus Laser Closure) technique under local anesthesia, and the other receiving combined treatment with phenol application followed by laser treatment. Both procedures are minimally invasive, performed as day surgeries with local anesthesia, and patients receive standard post-operative wound care before being discharged the same day. During the study, participants will have a preoperative assessment and follow-up visits at 2 weeks, 4 weeks, and 3 months. Researchers will evaluate healing through clinical examinations for epithelialization, measure pain levels using a visual scale, assess quality of life with questionnaires, and track time to return to daily activities. The primary outcome is the time to complete epithelialization, with additional monitoring of pain, complications, patient satisfaction, and quality of life over three months.
CONDITIONS
Brief Title
Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either laser treatment alone or combined crystallized phenol application followed by laser treatment for pilonidal sinus disease under local anesthesia with same-day discharge.
1 treatment visit (in-person)
Duration - 3 months
Participants attend postoperative visits for clinical examination of healing, pain assessment, and quality of life evaluation.
3 visits at 2 weeks, 4 weeks, and 3 months (in-person)
Trial Site Locations
Total: 1 location
1
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Other, Turkey (Türkiye), 34785
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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