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

Not Applicable

• Conditions: Pilonidal Sinus
• Interventions: Drug: Crystallized phenol; Procedure: Limberg Flap; Procedure: Modified Limberg Flap; Procedure: Karydakis Flap

• Registration Number: NCT01792557
• Lead Sponsor: S.B. Konya Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Start: 2013-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenol	Crystallized phenol	Crystallized Phenol Group
Limberg	Limberg Flap	Limberg Flap Group
Modified Limberg	Modified Limberg Flap	Modified Limberg Flap Group
Karydakis	Karydakis Flap	Karydakis Flap Group

Primary Outcome Measures

Name	Time	Method
Assessment of recurrence	3rd year	Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.

Secondary Outcome Measures

Name	Time	Method
Assessment of patient comfort	1st year	Patients will be queried for patient comfort at the end of first year
Assessment of recovery duration	3rd month	Post procedure wound recovery duration will be recorded
Assessment of complications	3rd month	Patients will be followed up for procedure related complications.

Trial Locations

Locations (1)

Konya Education and Research Hospital; 🇹🇷 Meram, Konya, Turkey