Ghnnam Excision Technique for Pilonidal Sinus

Surgical Wound Clinical Trial

Official title:

Ghnnam Excision Technique for Pilonidal Sinus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399320
• Other study ID #: MansouraU
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2011
• Last updated: July 20, 2011
• Start date: August 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2008
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any patient with pilonidal sinus

Exclusion Criteria:

• pilonidal abscess or sever acute inflammation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dressing by Cyanoacrylate
• Pilonidal Sinus
• Surgical Wound

Intervention

Procedure:
• cyanoacrylate
excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing

Locations

Country	Name	City	State
Egypt	Mansoura Faculty of Medicine	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing of the sinus		1 month	Yes
Secondary	recurrence	no recurrence	1 year	Yes
Secondary	wound infection	occurrence of wound sepsis	3-6 months	No
Secondary	patient satisfaction	patient satisfied with the procedure	3 months	No