- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01399320
Ghnnam Excision Technique for Pilonidal Sinus
July 20, 2011 updated by: Mansoura University
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
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35665
- Mansoura faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- any patient with pilonidal sinus
Exclusion Criteria:
- pilonidal abscess or sever acute inflammation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cyanoacrylate dressing,excesion
we excise the sinus tip then apply cyanoacrylate dressing and watch for healing
|
excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
healing of the sinus
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence
Time Frame: 1 year
|
no recurrence
|
1 year
|
wound infection
Time Frame: 3-6 months
|
occurrence of wound sepsis
|
3-6 months
|
patient satisfaction
Time Frame: 3 months
|
patient satisfied with the procedure
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: wagih m ghnnam, MD, mansoura faculty of medicine general surgery department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 19, 2011
First Submitted That Met QC Criteria
July 20, 2011
First Posted (Estimate)
July 21, 2011
Study Record Updates
Last Update Posted (Estimate)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 20, 2011
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MansouraU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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