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

Uppsala University

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: Laying open; Procedure: Sinus excision

Study type: Interventional

Funder types: Other

Identifiers

NCT00997048

EPN 2002/139

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Active signs of infection prohibiting primary sewing of the wound

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Laying open

Experimental group

Treatment:

Procedure: Laying open

Sinus excision

Active Comparator group

Treatment:

Procedure: Sinus excision