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

October 15, 2009 updated by: Uppsala University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital, surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing frequency
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pain according to a visual analogue scale
Time Frame: 7 days
7 days
scar/wound length
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Wilhelm Graf, MD, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (ESTIMATE)

October 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2009

Last Update Submitted That Met QC Criteria

October 15, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN 2002/139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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