NCT04194541

Brief Summary

The primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 14, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

December 9, 2019

Results QC Date

July 24, 2022

Last Update Submit

March 10, 2023

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

  • Dermatology Life Quality Index (DLQI) Scores

    Participant quality of life as measured via DLQI. DLQI has a total score ranging from 0-30 with the higher score indicating more impairment on the participant's quality of life.

    At Baseline, at 6 Weeks

Secondary Outcomes (9)

  • Average Pain as Assessed by the Numerical Rating Scale (NRS)

    At Baseline, at 6 Weeks

  • Maximal Pain as Assessed by the Numerical Rating Scale (NRS)

    At Baseline, at 6 Weeks

  • Sleep Rating

    At Baseline, at 6 Weeks

  • Drainage Rating

    At Baseline, at 6 Weeks

  • Odor Rating

    At Baseline, at 6 Weeks

  • +4 more secondary outcomes

Study Arms (1)

Treatment Group

EXPERIMENTAL

Participants will be provided a kit containing 3 dressings: Cutimed Sorbact Hydroactive B, Cutimed Siltec, and Sorbion Sana multi-star. Participant can use their dressing of choice and can change their dressings as needed for 6 consecutive weeks.

Device: Cutimed Sorbact Hydroactive B wound dressingDevice: Cutimed Siltect wound dressingDevice: Sorbion Sana multi-star wound dressing

Interventions

Cutimed Sorbact Hydroactive B wound dressingDEVICE

Wound dressing applied and changed as needed.

Treatment Group
Cutimed Siltect wound dressingDEVICE

Wound dressing applied and changed as needed.

Treatment Group
Sorbion Sana multi-star wound dressingDEVICE

Wound dressing applied and changed as needed.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥18 years of age
  • Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
  • Presence of at least one lesion with active drainage
  • Willing and able to provide informed consent

You may not qualify if:

  • Subjects younger than 18-years-old.
  • Prisoners
  • Pregnant or lactating women
  • Adults unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

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

Results Point of Contact

Title
Hadar Lev-Tov, MD
Organization
University of Miami
hlevtov@med.miami.edu
305-243-4472

Study Officials

  • Hadar Lev-Tov, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

January 28, 2020

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

March 14, 2023

Results First Posted

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)