NCT02593604

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

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

March 15, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

April 11, 2015

Last Update Submit

October 11, 2017

Conditions

Hidradenitis SuppurativaWide Excision

Keywords

Hidradenitis suppurativaWide excisionQuality of LifeSexual Function

Outcome Measures

Primary Outcomes (4)

  • Quality of Life (WHOQOL-BREF)

    Quality of Life is checked by WHOQOL-BREF

    2 years postop

  • Quality of Life (DLQI)

    Quality of Life is checked by DLQI

    2 years postop

  • Quality of Life (FLQA-d)

    Quality of Life is checked by FLQA-d

    2 years postop

  • Quality of Life (Skindex)

    Quality of Life is checked by Skindex

    2 years postop

Secondary Outcomes (5)

  • Sexual Function

    2 years postop

  • Demographic Parameters

    2 years postop

  • Smoking

    2 years postop

  • Weight and height

    2 years postop

  • Wound assessment

    2 years postop

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.

You may qualify if:

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

You may not qualify if:

  • Non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • Tobias Kisch, MD

    University of Schleswig-Holstein, Campus Lübeck, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 11, 2015

First Posted

November 2, 2015

Study Start

March 15, 2015

Primary Completion

April 15, 2017

Study Completion

April 15, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

DE(1)