Back to resultsGhnnam Excision Technique for Pilonidal Sinus
Primary Purpose
Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
cyanoacrylate
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring Pilonidal disease, Excision, cyanoacrylate
Eligibility Criteria
Inclusion Criteria:
- any patient with pilonidal sinus
Exclusion Criteria:
- pilonidal abscess or sever acute inflammation
Sites / Locations
- Mansoura Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cyanoacrylate dressing,excesion
Arm Description
we excise the sinus tip then apply cyanoacrylate dressing and watch for healing
Outcomes
Primary Outcome Measures
healing of the sinus
Secondary Outcome Measures
recurrence
no recurrence
wound infection
occurrence of wound sepsis
patient satisfaction
patient satisfied with the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01399320
Brief Title
Ghnnam Excision Technique for Pilonidal Sinus
Official Title
Ghnnam Excision Technique for Pilonidal Sinus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus, Surgical Wound, Dressing by Cyanoacrylate
Keywords
Pilonidal disease, Excision, cyanoacrylate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cyanoacrylate dressing,excesion
Arm Type
Experimental
Arm Description
we excise the sinus tip then apply cyanoacrylate dressing and watch for healing
Intervention Type
Procedure
Intervention Name(s)
cyanoacrylate
Other Intervention Name(s)
histoacryl
Intervention Description
excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing
Primary Outcome Measure Information:
Title
healing of the sinus
Time Frame
1 month
Secondary Outcome Measure Information:
Title
recurrence
Description
no recurrence
Time Frame
1 year
Title
wound infection
Description
occurrence of wound sepsis
Time Frame
3-6 months
Title
patient satisfaction
Description
patient satisfied with the procedure
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any patient with pilonidal sinus
Exclusion Criteria:
pilonidal abscess or sever acute inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wagih m ghnnam, MD
Organizational Affiliation
mansoura faculty of medicine general surgery department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura Faculty of Medicine
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35665
Country
Egypt
12. IPD Sharing Statement
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Ghnnam Excision Technique for Pilonidal Sinus
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