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Completed

NCT Number: NCT00997048

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

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, surgery

Uppsala, 751 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active signs of infection prohibiting primary sewing of the wound

Treatment and study plan

Laying open

Procedure

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

Sinus excision

Procedure

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

Primary outcomes

  1. Healing frequency

    Time frame: 12 months

Secondary outcomes

  1. pain according to a visual analogue scale

    Time frame: 7 days

  2. scar/wound length

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Oct 16, 2009
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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