NCT00997048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

3.4 years

First QC Date

October 15, 2009

Last Update Submit

October 15, 2009

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Healing frequency

    12 months

Secondary Outcomes (2)

  • pain according to a visual analogue scale

    7 days

  • scar/wound length

    12 months

Study Arms (2)

Laying open

EXPERIMENTAL
Procedure: Laying open

Sinus excision

ACTIVE COMPARATOR
Procedure: Sinus excision

Interventions

Laying openPROCEDURE

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

Laying open
Sinus excisionPROCEDURE

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

Sinus excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active signs of infection prohibiting primary sewing of the wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, surgery

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21304300DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Wilhelm Graf, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

October 1, 2002

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

SE(1)