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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997048
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : October 16, 2009
Information provided by:
Uppsala University

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 Phase
Pilonidal Sinus Procedure: Laying open Procedure: Sinus excision Not Applicable

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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
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00997048

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Uppsala University Hospital, surgery
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
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Principal Investigator: Wilhelm Graf, MD, PhD Uppsala University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Wilhelm Graf, Uppsala University Identifier: NCT00997048    
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:
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Pilonidal Sinus