LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanliurfa Education and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
Uncomplicated disease
Suitability for minimally invasive treatment
Disqualifiers
Acute pilonidal abscess
History of pilonidal abscess drainage
Previous surgical or interventional treatment for pilonidal sinus disease
Recurrent pilonidal disease
Trial design
Design model
Parallel
Treatments tested in this trial
Laser Ablation
Procedure/SurgeryAfter 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/SurgeryAfter a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Laser ablationExperimental treatment 1 intervention
Group B: Crystallized phenolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Postoperative day 1Secondary outcomes
1
Complete epithelialization at day 30
Presence or absence of complete epithelialization of the wound at postoperative day 30.
Time frame
Postoperative day 302
Time to complete epithelialization
Time from treatment to complete epithelialization, measured in days.
Time frame
Up to 30 days3
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.
Time frame
Postoperative day 74
Duration of analgesic use
Duration of postoperative analgesic use, measured in days.
Time frame
Up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov