Wound Dressings for Hidradenitis Suppurativa

Not Applicable

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Device: Cutimed Sorbact Hydroactive B wound dressing; Device: Cutimed Siltect wound dressing; Device: Sorbion Sana multi-star wound dressing

• Registration Number: NCT04194541
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-01-28
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Results First Submitted: 2022-07-24
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Results First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Cutimed Siltect wound dressing	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.
Treatment Group	Sorbion Sana multi-star wound dressing	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.
Treatment Group	Cutimed Sorbact Hydroactive B wound dressing	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.

Primary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI) Scores	At Baseline, at 6 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Dressing Preference for Each Specific Body Part	Visit 1 (Day 14)	Participant reported dressing preference for specific body parts for each of the interventions received.
Average Frequency of Dressing Changes	6 Weeks	Participant reported frequency of dressing changes per wound per day. For participants with multiple wounds/lesions, the frequency of dressing changes will be a comprehensive assessment of all wounds/lesions.
Odor Rating	At Baseline, at 6 Weeks	Lesion odor rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion odor. For participants with multiple wounds/lesions, the odor rating will be a comprehensive assessment of all wounds/lesions.
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading	At 6 Weeks	HS-PGA Scale scores patient disease severity as one of the following: clear, minimal, mild, moderate, severe, and very severe. The number of participants scored at each scale will be reported.
Average Pain as Assessed by the Numerical Rating Scale (NRS)	At Baseline, at 6 Weeks	The average pain reported over the last 24 hours will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Number of Participants Reporting Overall Dressing Preference for Specific Body Part	At Baseline	Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)	At Baseline, at 6 Weeks	The pain rating at its worse over the last 24 hours will be reported as the maximal pain using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Sleep Rating	At Baseline, at 6 Weeks	Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.
Drainage Rating	At Baseline, at 6 Weeks	Lesion drainage rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion draining. For participants with multiple wounds/lesions, the drainage rating will be a comprehensive assessment of all wounds/lesions.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States