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

March 21, 2014 updated by: S.B. Konya Education and Research Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Konya
      • Meram, Konya, Turkey, 42040
        • Konya Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Phenol
Crystallized Phenol Group
Drug: 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
Limberg Flap Group
Procedure: Limberg Flap
Limberg Flap surgery for pilonidal disease treatment
ACTIVE_COMPARATOR: Modified Limberg
Modified Limberg Flap Group
Procedure: 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
Karydakis Flap Group
Procedure: Karydakis Flap
Karydakis Flap surgery for pilonidal disease treatment

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of time before patient returns to work/routine physical activity
Time Frame: 3rd month
Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.
3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.B. Konya Education and Research Hospital

Investigators

  • Study Director: Osman Doğru, M.D., Konya Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEAH06021301
  • U1111-1139-3538 (OTHER: WHO Universal Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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