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CompletedNCT00997048Updated Oct 16, 2009

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

An interventional study of Laying open and Sinus excision in Pilonidal Sinus, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-16.

Sponsored by Uppsala University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pilonidal Sinus

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03

In context

Pilonidal Sinus

107 studies on the registry are indexed under Pilonidal Sinus; 31 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 73 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active signs of infection prohibiting primary sewing of the wound
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Laying open

    Procedure: Laying open

  • Active comparator
    Sinus excision

    Procedure: Sinus excision

Interventions

  • ProcedureLaying open

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

  • ProcedureSinus excision

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

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What researchers measure

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

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Study locations

1 site
  • Uppsala University Hospital, surgery
    Uppsala, 751 85, Sweden
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References and documents

Publications

  • 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. PubMed 21304300 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00997048
Lead sponsor
Uppsala University
First posted
Oct 16, 2009
Start date
Oct 2002
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Oct 16, 2009

Study contacts

Wilhelm Graf, MD, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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