Overview

This trial is active, not recruiting.

Condition pilonidal sinus
Treatments crystallized phenol, limberg flap, modified limberg flap, karydakis flap
Sponsor S.B. Konya Education and Research Hospital
Start date March 2013
End date March 2017
Trial size 200 participants
Trial identifier NCT01792557, KEAH06021301, U1111-1139-3538

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Crystallized Phenol Group
crystallized phenol
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.
(Active Comparator)
Limberg Flap Group
limberg flap
Limberg Flap surgery for pilonidal disease treatment
(Active Comparator)
Modified Limberg Flap Group
modified limberg flap
Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.
(Active Comparator)
Karydakis Flap Group
karydakis flap
Karydakis Flap surgery for pilonidal disease treatment

Primary Outcomes

Measure
Assessment of recurrence
time frame: 3rd year

Secondary Outcomes

Measure
Assessment of patient comfort
time frame: 1st year
Assessment of recovery duration
time frame: 3rd month
Assessment of complications
time frame: 3rd month

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by S.B. Konya Education and Research Hospital.