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Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716937
First Posted: July 16, 2008
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  Purpose
Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011

Condition Intervention Phase
Pilonidal Sinus Pilonidal Cyst Procedure: karydakis flap Procedure: laying open Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recurrence, Complications, Work-off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Excision With Healing by Secondary Intention (EHSI)Technique

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 1 year after surgery ]

Secondary Outcome Measures:
  • Work off date, Healing Time [ Time Frame: up to 1 Year after surgery ]

Enrollment: 321
Study Start Date: September 2007
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Excision of the cyst and Karydakis flap
Procedure: karydakis flap
Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft
Other Names:
  • lateralization
  • primary repair
Experimental: 2
Excision of the cyst and laying open
Procedure: karydakis flap
Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft
Other Names:
  • lateralization
  • primary repair
Procedure: laying open
laying open the site of excision of sinus or cyst without any flap

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00716937


Locations
Iran, Islamic Republic of
Tehran University of medical Sciences, Deputy of Research
Tehran, Iran, Islamic Republic of, 23
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Amir Keshvari, Assoc. Prof. Tehran University of Medical Sciences
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00716937     History of Changes
Other Study ID Numbers: 6148
86-04-30-6148 ( Other Identifier: Tehran University of Medical Sciences )
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Tehran University of Medical Sciences:
pilonidal sinus
karydakis
laying open

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms