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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00997048
Enrollment
80
Registered
2009-10-16
Start date
2002-10-31
Completion date
2006-03-31
Last updated
2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

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.

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

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Active signs of infection prohibiting primary sewing of the wound

Design outcomes

Primary

MeasureTime frame
Healing frequency12 months

Secondary

MeasureTime frame
pain according to a visual analogue scale7 days
scar/wound length12 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026