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Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT02593604
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Fachklinik Hornheide an der Universität Münster
Information provided by (Responsible Party):
Tobias Kisch, University of Schleswig-Holstein

Brief 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).

Condition or disease
Hidradenitis Suppurativa Wide Excision

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
Actual Study Start Date : March 15, 2015
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Quality of Life (WHOQOL-BREF) [ Time Frame: 2 years postop ]
    Quality of Life is checked by WHOQOL-BREF

  2. Quality of Life (DLQI) [ Time Frame: 2 years postop ]
    Quality of Life is checked by DLQI

  3. Quality of Life (FLQA-d) [ Time Frame: 2 years postop ]
    Quality of Life is checked by FLQA-d

  4. Quality of Life (Skindex) [ Time Frame: 2 years postop ]
    Quality of Life is checked by Skindex


Secondary Outcome Measures :
  1. Sexual Function [ Time Frame: 2 years postop ]
    Sexual Function is checked by IIEF (male) and FSFI (female)

  2. Demographic Parameters [ Time Frame: 2 years postop ]
    Patients' history

  3. Smoking [ Time Frame: 2 years postop ]
    Smoking

  4. Weight and height [ Time Frame: 2 years postop ]
    Weight and height

  5. Wound assessment [ Time Frame: 2 years postop ]
    Localization, Hurley Stage, pain before operation



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.
Criteria

Inclusion Criteria:

  • Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
  • Agreed to retrospective analysis and questionnaires

Exclusion Criteria:

  • Non-compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593604


Locations
Germany
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Schleswig-Holstein
Fachklinik Hornheide an der Universität Münster
Investigators
Study Director: Tobias Kisch, MD University of Schleswig-Holstein, Campus Lübeck, Germany

Responsible Party: Tobias Kisch, MD, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02593604     History of Changes
Other Study ID Numbers: 14-015
U1111-1176-0162 ( Other Identifier: WHO )
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Tobias Kisch, University of Schleswig-Holstein:
Hidradenitis suppurativa
Wide excision
Quality of Life
Sexual Function

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration