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

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01792557
• Other study ID #: KEAH06021301
• Secondary ID: U1111-1139-3538
• Status: Active, not recruiting
• Phase: N/A
• First received: February 11, 2013
• Last updated: March 21, 2014
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: March 2014
• Source: S.B. Konya Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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.

Procedure:
• Limberg Flap
Limberg Flap surgery for pilonidal disease treatment
• 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.
• Karydakis Flap
Karydakis Flap surgery for pilonidal disease treatment

Locations

Country	Name	City	State
Turkey	Konya Education and Research Hospital	Meram	Konya

Sponsors (1)

Lead Sponsor	Collaborator
S.B. Konya Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Akin M, Leventoglu S, Mentes BB, Bostanci H, Gokbayir H, Kilic K, Ozdemir E, Ferahkose Z. Comparison of the classic Limberg flap and modified Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010 Aug;40(8):757-62. doi: 10.1007/s00595-008-4098-7. Epub 2010 Jul 30. — View Citation

Cihan A, Mentes BB, Tatlicioglu E, Ozmen S, Leventoglu S, Ucan BH. Modified Limberg flap reconstruction compares favourably with primary repair for pilonidal sinus surgery. ANZ J Surg. 2004 Apr;74(4):238-42. — View Citation

Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. — View Citation

Keshava A, Young CJ, Rickard MJ, Sinclair G. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg. 2007 Mar;77(3):181-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of time before patient returns to work/routine physical activity	Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.	3rd month	No
Primary	Assessment of recurrence	Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.	3rd year	No
Secondary	Assessment of patient comfort	Patients will be queried for patient comfort at the end of first year	1st year	No
Secondary	Assessment of recovery duration	Post procedure wound recovery duration will be recorded	3rd month	No
Secondary	Assessment of complications	Patients will be followed up for procedure related complications.	3rd month	No