Pilonidal SinusNCT01889394
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
A study testing secondary wound healing and primary wound closure using a limberg flap in people with Pilonidal Sinus, run by Kantonsspital Liestal at 3 sites in Switzerland.
Trial summary
To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- secondary wound healing and primary wound closure using a limberg flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2006to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for excision of pilonidal sinus given
Who cannot join
- limberg flap not possible for surgical reasons
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kantonsspital Liest
Liestal, Basel-Landschaft, 4410
Gesundheitszentrum Fricktal
Rheinfelden, Canton of Aargau
Spitalzentrum Oberwallis
Visp, Valais, 3930
About this study
Official title: Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial
To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.
Read the detailed description
Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).
- Conditions
- Pilonidal Sinus
- Being tested
- secondary wound healing, primary wound closure using a limberg flap
- Keywords
- pilonidal sinus, excision, primary wound closure, limberg flap
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secondary wound healingProcedure or surgery
secondary wound healing
primary wound closure using a limberg flapProcedure or surgery
primary wound closure using a limberg flap
| Study group | Role | What they receive |
|---|---|---|
| limberg flap | Active comparator | primary wound closure using a limberg flap Receives: Procedure: primary wound closure using a limberg flap |
| secondary wound healing | Active comparator | secondary wound healing Receives: Procedure: secondary wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inability to work
change for capacity for work at one year post-OP
Measured: 1 year
Secondary outcomes (4)
Pain perioperatively and after 3 weeks
Measured: 0 and 3 weeks
Complication rate after 3 weeks
Measured: 3 weeks
Patient satisfaction after 3 weeks & 1year
Measured: 3 weeks and 1 year
Recurrence rate after 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2006
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph A Maurer, Prof Dr med, Principal investigator, Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889394
- Sponsor's protocol ID
- UKBB 234/05
- Status last verified
- Aug 2017
- First submitted
- 24 Jun 2013
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01889394
- Acronym / sponsor ID
- UKBB 234/05
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal sinus, excision, primary wound closure, limberg flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.
Detailed description
Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| limberg flap | Active comparator | Procedure: primary wound closure using a limberg flapprimary wound closure using a limberg flap |
| secondary wound healing | Active comparator | Procedure: secondary wound healingsecondary wound healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for excision of pilonidal sinus given
Key exclusion criteria (1 listed)
- limberg flap not possible for surgical reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secondary wound healingsecondary wound healing | Procedure or surgery | secondary wound healing |
| primary wound closure using a limberg flapprimary wound closure using a limberg flap | Procedure or surgery | limberg flap |
Primary outcome
Inability to work
Time frame: 1 year
change for capacity for work at one year post-OP
4 secondary outcomes
Pain perioperatively and after 3 weeks
Time frame: 0 and 3 weeks
Complication rate after 3 weeks
Time frame: 3 weeks
Patient satisfaction after 3 weeks & 1year
Time frame: 3 weeks and 1 year
Recurrence rate after 1 year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph A Maurer, Prof Dr med principal investigator
Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing secondary wound healing and primary wound closure using a limberg flap in people with Pilonidal Sinus, run by Kantonsspital Liestal at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inability to work (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017; AzTrials last refreshed its copy on 31 Oct 2026.