Trial record 3 of 7 for:    Open Studies | "Pilonidal Sinus"

Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus. (BAVUGC-2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Bezmialem Vakif University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Suleyman Bozkurt, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01513382
First received: January 17, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.


Condition Intervention
Pilonidal Sinus
Procedure: Pilonidal sinus excision

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylene Blue
The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.
Procedure: Pilonidal sinus excision
The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.

Detailed Description:

To study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. The branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pilonidal sinus disease of the intergluteal region
  • Primary disease without history of drainage
  • Ages between 18 and 65, both gender

Exclusion Criteria:

  • Recurrent pilonidal sinus disease
  • Acute infection with abscess formation and/or purulent copious drainage
  • Denial to sign informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513382

Contacts
Contact: Erhan Aysan, Prof Dr +902125233719 dr@webcerrah.com

Locations
Turkey
Bezmialem Vakif University, Faculty of Medicine, Department of Surgery Not yet recruiting
Istanbul, Turkey, 34093
Principal Investigator: Suleyman Bozkurt, M.D.         
Sub-Investigator: Erhan Aysan, Prof. Dr.         
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Principal Investigator: Suleyman Bozkurt, M.D. Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Study Director: Erhan Aysan, Prof. Dr. Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
  More Information

Publications:
Responsible Party: Suleyman Bozkurt, Medical Doctor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01513382     History of Changes
Other Study ID Numbers: BAVUGC-2
Study First Received: January 17, 2012
Last Updated: January 19, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Bezmialem Vakif University:
Pilonidal sinus
Methylene blue
Histopathology
Surgery

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014