Quality of Life After Wide Surgical Excision in Patients... | NCT02593604

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

NCT02593604

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Oct 12, 2017Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hidradenitis Suppurativa
Wide Excision

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1176-0162	Other Identifier	WHO

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2015Actual

Primary Completion Date

Apr 15, 2017Actual

Completion Date

Apr 15, 2017Actual

First Submitted Date

Apr 11, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Nov 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Name	Class
Fachklinik Hornheide an der Universität Münster	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sexual Function	Sexual Function is checked by IIEF (male) and FSFI (female)	2 years postop
Demographic Parameters	Patients' history

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Kisch, MD	University of Schleswig-Holstein, Campus Lübeck, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Schleswig-Holstein		Lübeck	Schleswig-Holstein	23538	Germany

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided