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

October 15, 2009
October 15, 2009
October 2002
March 2006   (final data collection date for primary outcome measure)
Healing frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study
Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pilonidal Sinus
  • Procedure: Laying open
    Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg
  • Procedure: Sinus excision
    Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg
  • Experimental: Laying open
    Intervention: Procedure: Laying open
  • Active Comparator: Sinus excision
    Intervention: Procedure: Sinus excision
Lorant T, Ribbe I, Mahteme H, Gustafsson UM, Graf W. Sinus excision and primary closure versus laying open in pilonidal disease: a prospective randomized trial. Dis Colon Rectum. 2011 Mar;54(3):300-5. doi: 10.1007/DCR.0b013e31820246bf.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Active signs of infection prohibiting primary sewing of the wound
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00997048
EPN 2002/139
No
Professor Wilhelm Graf, Uppsala University
Uppsala University
Not Provided
Principal Investigator: Wilhelm Graf, MD, PhD Uppsala University
Uppsala University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP