Hidradenitis SuppurativaNCT02593604
Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa and Wide Excision, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hidradenitis Suppurativa, Wide Excision
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2015to 15 Apr 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.
Who may be able to join
- Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
- Agreed to retrospective analysis and questionnaires
Who cannot join
- Non-compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).
- Conditions
- Hidradenitis Suppurativa, Wide Excision
- Keywords
- Hidradenitis suppurativa, Wide excision, Quality of Life, Sexual Function
- Medical subject headings
- Hidradenitis Suppurativa
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (WHOQOL-BREF)
Quality of Life is checked by WHOQOL-BREF
Measured: 2 years postop
Quality of Life (DLQI)
Quality of Life is checked by DLQI
Measured: 2 years postop
Quality of Life (FLQA-d)
Quality of Life is checked by FLQA-d
Measured: 2 years postop
Quality of Life (Skindex)
Quality of Life is checked by Skindex
Measured: 2 years postop
Secondary outcomes (5)
Sexual Function
Sexual Function is checked by IIEF (male) and FSFI (female)
Measured: 2 years postop
Demographic Parameters
Patients' history
Measured: 2 years postop
Smoking
Smoking
Measured: 2 years postop
Weight and height
Weight and height
Measured: 2 years postop
Wound assessment
Localization, Hurley Stage, pain before operation
Measured: 2 years postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start15 Mar 2015
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fachklinik Hornheide an der Universität Münster
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Tobias Kisch, MD, Study director, University of Schleswig-Holstein, Campus Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593604
- Sponsor's protocol ID
- 14-015
- Other IDs
- U1111-1176-0162
- Status last verified
- Oct 2017
- First submitted
- 11 Apr 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT02593604
- Acronym / sponsor ID
- 14-015
- Conditions
- Hidradenitis Suppurativa, Wide Excision
- Keywords
- Hidradenitis suppurativa, Wide excision, Quality of Life, Sexual Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Fachklinik Hornheide an der Universität Münster
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 2 Nov 2015 (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.
Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.
Key inclusion criteria (2 listed)
- Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
- Agreed to retrospective analysis and questionnaires
Key exclusion criteria (1 listed)
- Non-compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life (WHOQOL-BREF)
Time frame: 2 years postop
Quality of Life is checked by WHOQOL-BREF
Quality of Life (DLQI)
Time frame: 2 years postop
Quality of Life is checked by DLQI
Quality of Life (FLQA-d)
Time frame: 2 years postop
Quality of Life is checked by FLQA-d
Quality of Life (Skindex)
Time frame: 2 years postop
Quality of Life is checked by Skindex
5 secondary outcomes
Sexual Function
Time frame: 2 years postop
Demographic Parameters
Time frame: 2 years postop
Smoking
Time frame: 2 years postop
Weight and height
Time frame: 2 years postop
Wound assessment
Time frame: 2 years postop
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 12 Oct 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.
Tobias Kisch, MD study director
University of Schleswig-Holstein, Campus Lübeck, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa and Wide Excision, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 2 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Quality of Life (WHOQOL-BREF) (time frame: 2 years postop). The study lists 4 primary outcomes in all. 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 12 Oct 2017.