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

Not Applicable

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: Laying open; Procedure: Sinus excision

• Registration Number: NCT00997048
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Last Update Submitted: 2009-10-15
• Study First Posted: 2009-10-16
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laying open	Laying open	-
Sinus excision	Sinus excision	-

Primary Outcome Measures

Name	Time	Method
Healing frequency	12 months

Secondary Outcome Measures

Name	Time	Method
pain according to a visual analogue scale	7 days
scar/wound length	12 months

Trial Locations

Locations (1)

Uppsala University Hospital, surgery; 🇸🇪 Uppsala, Sweden