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

Primary Purpose

Pilonidal Sinus

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Laying open

Sinus excision

About this trial

This is an interventional treatment trial for Pilonidal Sinus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Uppsala University Hospital, surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laying open

Sinus excision

Arm Description

Outcomes

Primary Outcome Measures

Healing frequency

Secondary Outcome Measures

pain according to a visual analogue scale

scar/wound length

Full Information

NCT ID

NCT00997048

First Posted

October 15, 2009

Last Updated

October 15, 2009

Sponsor

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT00997048

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Uppsala University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pilonidal Sinus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laying open

Arm Type

Experimental

Arm Title

Sinus excision

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Laying open

Intervention Description

Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg

Intervention Type

Procedure

Intervention Name(s)

Sinus excision

Intervention Description

Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg

Primary Outcome Measure Information:

Title

Healing frequency

Time Frame

12 months

Secondary Outcome Measure Information:

Title

pain according to a visual analogue scale

Time Frame

7 days

Title

scar/wound length

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pilonidal sinus eligible for surgery Age > 18 years Swedish speaking Exclusion Criteria: Active signs of infection prohibiting primary sewing of the wound

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilhelm Graf, MD, PhD

Organizational Affiliation

Uppsala University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uppsala University Hospital, surgery

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

21304300

Citation

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.

Results Reference

derived

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

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