Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorIzmir City Hospital

About this trial

Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques.

The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost.

Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 64 years

Diagnosis of primary pilonidal sinus disease

Maximum of three sinus openings (pits)

History of no more than two previous abscess episodes

Disqualifiers

Recurrent or previously operated pilonidal sinus disease

More than three sinus openings

More than two previous abscess episodes

Acute abscess requiring emergency drainage at presentation

Trial design

Design model

Parallel

Treatments tested in this trial

  • SiLac (Laser Ablation)

    Procedure/Surgery

    Laser ablation of the pilonidal sinus tract performed according to the study protocol.

  • Phenol Application

    Procedure/Surgery

    Chemical ablation with phenol performed according to the study protocol.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: SiLAc GroupExperimental treatment 1 intervention
Group B: Phenol GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence Rate

Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up.

Time frame
6 month

Secondary outcomes

1

Postoperative Pain (VAS Score)

Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).

Time frame
Postoperative day 1 and week 1
2

Postoperative Analgesic Consumption

Use of analgesic medication after treatment, measured as the proportion of patients requiring analgesics and/or the total number of analgesic doses used during the early postoperative period.

Time frame
Within the first postoperative week
3

Wound Healing Time

Time required for complete epithelialization of the treated area without discharge.

Time frame
Up to 6 months
4

Wound-Related Complications

Occurrence of wound-related complications, including infection, abscess formation, cellulitis, seroma/hematoma, prolonged discharge (\>30 days), or need for additional medical or surgical intervention. Early (≤30 days) and late (\>30 days to 6 months) complications will be recorded separately.

Time frame
Within 6 months after treatment

Other outcomes

Sponsors and contacts

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