Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
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|ClinicalTrials.gov Identifier: NCT01792557|
Recruitment Status : Unknown
Verified March 2014 by S.B. Konya Education and Research Hospital.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pilonidal Sinus||Drug: Crystallized phenol Procedure: Limberg Flap Procedure: Modified Limberg Flap Procedure: Karydakis Flap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
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
- 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.
- Assessment of patient comfort [ Time Frame: 1st year ]Patients will be queried for patient comfort at the end of first year
- Assessment of recovery duration [ Time Frame: 3rd month ]Post procedure wound recovery duration will be recorded
- Assessment of complications [ Time Frame: 3rd month ]Patients will be followed up for procedure related complications.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792557
|Konya Education and Research Hospital|
|Meram, Konya, Turkey, 42040|
|Study Director:||Osman Doğru, M.D.||Konya Education and Research Hospital|