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

S.B. Konya Education and Research Hospital

Status: Unknown

Conditions: Pilonidal Sinus

Treatments: Procedure: Limberg Flap; Procedure: Modified Limberg Flap; Procedure: Karydakis Flap; Drug: Crystallized phenol

Study type: Interventional

Funder types: Other

Identifiers

NCT01792557

U1111-1139-3538 (Other Identifier)

KEAH06021301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Phenol

Active Comparator group

Description:

Crystallized Phenol Group

Treatment:

Drug: Crystallized phenol

Limberg

Active Comparator group

Description:

Limberg Flap Group

Treatment:

Procedure: Limberg Flap

Modified Limberg

Active Comparator group

Description:

Modified Limberg Flap Group

Treatment:

Procedure: Modified Limberg Flap

Karydakis

Active Comparator group

Description:

Karydakis Flap Group

Treatment:

Procedure: Karydakis Flap