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Ghnnam Excision Technique for Pilonidal Sinus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399320
First Posted: July 21, 2011
Last Update Posted: July 21, 2011
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:
Mansoura University
  Purpose
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition

Condition Intervention Phase
Pilonidal Sinus Surgical Wound Dressing by Cyanoacrylate Procedure: cyanoacrylate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ghnnam Excision Technique for Pilonidal Sinus

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • healing of the sinus [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • recurrence [ Time Frame: 1 year ]
    no recurrence

  • wound infection [ Time Frame: 3-6 months ]
    occurrence of wound sepsis

  • patient satisfaction [ Time Frame: 3 months ]
    patient satisfied with the procedure


Enrollment: 40
Study Start Date: August 2008
Study Completion Date: June 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyanoacrylate dressing,excesion
we excise the sinus tip then apply cyanoacrylate dressing and watch for healing
Procedure: cyanoacrylate
excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing
Other Name: histoacryl

Detailed Description:
Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient with pilonidal sinus

Exclusion Criteria:

  • pilonidal abscess or sever acute inflammation
  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): NCT01399320


Locations
Egypt
Mansoura Faculty of Medicine
Mansoura, Dakahlia, Egypt, 35665
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: wagih m ghnnam, MD mansoura faculty of medicine general surgery department
  More Information

Responsible Party: Wagih Mommtaz Ghnnam, Mansoura faculty of medicine general surgery department
ClinicalTrials.gov Identifier: NCT01399320     History of Changes
Other Study ID Numbers: MansouraU
First Submitted: July 19, 2011
First Posted: July 21, 2011
Last Update Posted: July 21, 2011
Last Verified: August 2008

Keywords provided by Mansoura University:
Pilonidal disease
Excision
cyanoacrylate

Additional relevant MeSH terms:
Surgical Wound
Pilonidal Sinus
Wounds and Injuries
Cysts
Neoplasms