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

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ClinicalTrials.gov Identifier: NCT00997048
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : October 16, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pilonidal Sinus Procedure: Laying open Procedure: Sinus excision

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study
Study Start Date : October 2002
Primary Completion Date : March 2006
Study Completion Date : March 2006
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Healing frequency [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. pain according to a visual analogue scale [ Time Frame: 7 days ]
  2. scar/wound length [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997048

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

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
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Pilonidal Sinus