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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
S.B. Konya Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01792557
First received: February 11, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pilonidal Sinus
Drug: Crystallized phenol
Procedure: Limberg Flap
Procedure: Modified Limberg Flap
Procedure: Karydakis Flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by S.B. Konya Education and Research Hospital:

Primary Outcome Measures:
  • Assessment of recurrence [ Time Frame: 3rd year ] [ Designated as safety issue: No ]
    Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.


Secondary Outcome Measures:
  • Assessment of patient comfort [ Time Frame: 1st year ] [ Designated as safety issue: No ]
    Patients will be queried for patient comfort at the end of first year

  • Assessment of recovery duration [ Time Frame: 3rd month ] [ Designated as safety issue: No ]
    Post procedure wound recovery duration will be recorded

  • Assessment of complications [ Time Frame: 3rd month ] [ Designated as safety issue: No ]
    Patients will be followed up for procedure related complications.


Other Outcome Measures:
  • Assessment of time before patient returns to work/routine physical activity [ Time Frame: 3rd month ] [ Designated as safety issue: No ]
    Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792557

Locations
Turkey
Konya Education and Research Hospital
Meram, Konya, Turkey, 42040
Sponsors and Collaborators
S.B. Konya Education and Research Hospital
Investigators
Study Director: Osman Doğru, M.D. Konya Education and Research Hospital
  More Information

Publications:
Responsible Party: S.B. Konya Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01792557     History of Changes
Other Study ID Numbers: KEAH06021301, U1111-1139-3538
Study First Received: February 11, 2013
Last Updated: March 21, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by S.B. Konya Education and Research Hospital:
Pilonidal sinus
Crystallized phenol
Limberg Flap
Modified Limberg Flap
Karydakis
Recurrence
Complications
Recovery duration
Time to return to work

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms
Phenol
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Sclerosing Solutions
Cardiovascular Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on July 26, 2014