NCT01889394

Brief Summary

To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

January 1, 2006

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

7.6 years

First QC Date

June 24, 2013

Last Update Submit

August 29, 2017

Conditions

Pilonidal Sinus

Keywords

pilonidal sinusexcisionprimary wound closurelimberg flap

Outcome Measures

Primary Outcomes (1)

  • Inability to work

    change for capacity for work at one year post-OP

    1 year

Secondary Outcomes (4)

  • Pain perioperatively and after 3 weeks

    0 and 3 weeks

  • Complication rate after 3 weeks

    3 weeks

  • Patient satisfaction after 3 weeks & 1year

    3 weeks and 1 year

  • Recurrence rate after 1 year

    1 year

Study Arms (2)

limberg flap

ACTIVE COMPARATOR

primary wound closure using a limberg flap

Procedure: primary wound closure using a limberg flap

secondary wound healing

ACTIVE COMPARATOR

secondary wound healing

Procedure: secondary wound healing

Interventions

secondary wound healingPROCEDURE

secondary wound healing

secondary wound healing
primary wound closure using a limberg flapPROCEDURE

primary wound closure using a limberg flap

limberg flap

Eligibility Criteria

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

You may qualify if:

  • indication for excision of pilonidal sinus given

You may not qualify if:

  • limberg flap not possible for surgical reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kantonsspital Liest

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Gesundheitszentrum Fricktal

Rheinfelden, Canton of Aargau, Switzerland

Location

Spitalzentrum Oberwallis

Visp, Valais, 3930, Switzerland

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Christoph A Maurer, Prof Dr med

    Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 28, 2013

Study Start

January 1, 2006

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

CH(3)