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

NCT ID: NCT00997048

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laying open

Group Type EXPERIMENTAL

Laying open

Intervention Type PROCEDURE

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

Sinus excision

Group Type ACTIVE_COMPARATOR

Sinus excision

Intervention Type PROCEDURE

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

Interventions

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Laying open

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

Intervention Type PROCEDURE

Sinus excision

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pilonidal sinus eligible for surgery
* Age \> 18 years
* Swedish speaking

Exclusion Criteria

* Active signs of infection prohibiting primary sewing of the wound
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Principal Investigators

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Wilhelm Graf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Uppsala University Hospital, surgery

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 21304300 (View on PubMed)

Other Identifiers

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EPN 2002/139

Identifier Type: -

Identifier Source: org_study_id

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