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Ghnnam Excision Technique for Pilonidal Sinus

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01399320
First received: July 19, 2011
Last updated: July 20, 2011
Last verified: August 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    no recurrence

  • wound infection [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    occurrence of wound sepsis

  • patient satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient with pilonidal sinus

Exclusion Criteria:

  • pilonidal abscess or sever acute inflammation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wagih Mommtaz Ghnnam, Mansoura faculty of medicine general surgery department
ClinicalTrials.gov Identifier: NCT01399320     History of Changes
Other Study ID Numbers: MansouraU
Study First Received: July 19, 2011
Last Updated: July 20, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Pilonidal disease
Excision
cyanoacrylate

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013