Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study

Study Overview
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Brief Summary
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Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.

Detailed Description
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Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.

Official Title
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Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Drug: Crystallized phenol
* Procedure: Limberg Flap
* Procedure: Modified Limberg Flap
* Procedure: Karydakis Flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pilonidal disease Exclusion Criteria: Previous history of pilonidal disease treatment Pregnant or breast-feeding women Systemic diseases that would affect wound healing Diabetes Chronic renal failure Autoimmune diseases Malignant diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenol<br>Crystallized Phenol Group | Drug: Crystallized phenol<br>* Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks.<br>|
| Active Comparator: Limberg<br>Limberg Flap Group | Procedure: Limberg Flap<br>* Limberg Flap surgery for pilonidal disease treatment<br>|
| Active Comparator: Modified Limberg<br>Modified Limberg Flap Group | Procedure: Modified Limberg Flap<br>* Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.<br>|
| Active Comparator: Karydakis<br>Karydakis Flap Group | Procedure: Karydakis Flap<br>* Karydakis Flap surgery for pilonidal disease treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of recurrence | Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year. | 3rd year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient comfort | Patients will be queried for patient comfort at the end of first year | 1st year | 
| Assessment of recovery duration | Post procedure wound recovery duration will be recorded | 3rd month | 
| Assessment of complications | Patients will be followed up for procedure related complications. | 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilonidal sinus, Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis, Recurrence, Complications, Recovery duration, Time to return to work