Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

This study has been completed.
Sponsor:
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00997048
First received: October 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. The most common surgical procedure in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. This method, however, has some problems regarding healing and recidives. Therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. Healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured.


Condition Intervention
Pilonidal Sinus
Procedure: Laying open
Procedure: Sinus excision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Healing frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain according to a visual analogue scale [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • scar/wound length [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: October 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laying open Procedure: Laying open
Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg
Active Comparator: Sinus excision Procedure: Sinus excision
Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pilonidal sinus eligible for surgery
  • Age > 18 years
  • Swedish speaking

Exclusion Criteria:

  • Active signs of infection prohibiting primary sewing of the wound
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997048

Locations
Sweden
Uppsala University Hospital, surgery
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Wilhelm Graf, MD, PhD Uppsala University
  More Information

No publications provided by Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Wilhelm Graf, Uppsala University
ClinicalTrials.gov Identifier: NCT00997048     History of Changes
Other Study ID Numbers: EPN 2002/139
Study First Received: October 15, 2009
Last Updated: October 15, 2009
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014