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NCT00716937 Clinical Trial

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

Pilonidal Sinus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00716937
Other study ID # 6148
Secondary ID 86-04-30-6148
Status Completed
Phase Phase 4
First received July 14, 2008
Last updated December 15, 2014
Start date September 2007
Est. completion date March 2014

Study information
Verified date December 2014
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 321
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 90 Years
Eligibility Inclusion Criteria:

all types of pilonidal sinus or cyst

Exclusion Criteria:

no exclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• laying open
laying open the site of excision of sinus or cyst without any flap

Locations
Country Name City State
Iran, Islamic Republic of Tehran University of medical Sciences, Deputy of Research Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence 1 year after surgery Yes
Secondary Work off date, Healing Time up to 1 Year after surgery Yes
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Completed NCT01081522 - A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds N/A
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Active, not recruiting NCT01792557 - Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study N/A
Completed NCT02621879 - Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease N/A
Completed NCT00412659 - Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus Phase 2/Phase 3
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