Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work.

Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures.

The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period.

This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age under 18 years

More than three pit counts

Acute abscess presentation

Bilateral lateral extension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laser Treatment

    Procedure/Surgery

    Minimally invasive laser ablation procedure performed under local anesthesia for pilonidal sinus treatment. Laser energy is delivered through a fiber optic probe inserted into the sinus tract to achieve thermal ablation of the sinus cavity.

  • Crystallized Phenol

    Drug

    rystallized phenol is applied directly into the pilonidal sinus channels after cleaning and curettage. The phenol remains in contact for a specified duration before being neutralized with normal saline irrigation.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Laser Treatment OnlyActive comparator 1 intervention
Group B: Crystallized PhenolExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to Complete Epithelialization

Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area.

Time frame
From date of surgery until complete epithelialization is achieved, assessed up to 3 months

Secondary outcomes

1

Postoperative Pain Scores

Pain intensity measured using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable)

Time frame
Measured at 2 weeks, 4 weeks, and 3 months post-surgery
2

Return to Daily Activities Time

Time required for patients to return to normal daily activities and work, measured in days from surgery

Time frame
From date of surgery until return to normal activities, assessed up to 3 months
3

Complication Rate

Incidence of post-operative complications including infection, wound dehiscence, bleeding, or other adverse events

Time frame
From surgery through 3 months follow-up
4

Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction

Patient satisfaction measured using Visual Analog Scale (VAS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate better satisfaction

Time frame
At 3 months post-surgery

Other outcomes

Sponsors and contacts

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