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

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997048
• Other study ID #: EPN 2002/139
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: October 15, 2009
• Start date: October 2002
• Est. completion date: March 2006

Study information

• Verified date: October 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pilonidal sinus eligible for surgery

• Age > 18 years

• Swedish speaking

Exclusion Criteria:

• Active signs of infection prohibiting primary sewing of the wound

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• Laying open
Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg
• Sinus excision
Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, surgery	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing frequency		12 months	No
Secondary	pain according to a visual analogue scale		7 days	Yes
Secondary	scar/wound length		12 months	Yes