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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutimed Sorbact Hydroactive B wound dressing | Device | Wound dressing applied and changed as needed. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain as Assessed by the Numerical Rating Scale (NRS) | 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. | At Baseline, at 6 Weeks |
| Maximal Pain as Assessed by the Numerical Rating Scale (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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All participants were assigned to receive all three wound dressings and can choose to use whichever dressing they prefer. Each participant can have one or multiple wounds/lesions. Whether each participant had one or multiple of wounds/lesions was not data of interest. This information was not collected and included in the data analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | 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. Cutimed Sorbact Hydroactive B wound dressing: Wound dressing applied and changed as needed. Cutimed Siltect wound dressing: Wound dressing applied and changed as needed. Sorbion Sana multi-star wound dressing: Wound dressing applied and changed as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 0 (Baseline) |
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| Day 1 Through 13 |
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| Visit 1 (Day 14) |
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| Day 15 Through Week 6 |
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| Visit 2 (6 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | 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. Cutimed Sorbact Hydroactive B wound dressing: Wound dressing applied and changed as needed. Cutimed Siltect wound dressing: Wound dressing applied and changed as needed. Sorbion Sana multi-star wound dressing: Wound dressing applied and changed as needed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Median | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
|
6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 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. Cutimed Sorbact Hydroactive B wound dressing: Wound dressing applied and changed as needed. Cutimed Siltect wound dressing: Wound dressing applied and changed as needed. Sorbion Sana multi-star wound dressing: Wound dressing applied and changed as needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | 305-243-4472 | hlevtov@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2022 | Apr 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Cutimed Siltect wound dressing | Device | Wound dressing applied and changed as needed. |
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| Sorbion Sana multi-star wound dressing | Device | Wound dressing applied and changed as needed. |
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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. |
| At Baseline, at 6 Weeks |
| Sleep Rating | Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance. | At Baseline, at 6 Weeks |
| Drainage Rating | 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. | At Baseline, at 6 Weeks |
| Odor Rating | 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. | At Baseline, at 6 Weeks |
| Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | 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. | At 6 Weeks |
| Average Frequency of Dressing Changes | 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. | 6 Weeks |
| Number of Participants Reporting Overall Dressing Preference for Specific Body Part | Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided. | At Baseline |
| Number of Participants Reporting Dressing Preference for Each Specific Body Part | Participant reported dressing preference for specific body parts for each of the interventions received. | Visit 1 (Day 14) |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Average Pain as Assessed by the Numerical Rating Scale (NRS) | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Median | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
|
|
|
| Secondary | Maximal Pain as Assessed by the Numerical Rating Scale (NRS) | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Median | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
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| Secondary | Sleep Rating | Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Median | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
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|
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| Secondary | Drainage Rating | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Mean | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
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| Secondary | Odor Rating | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Median | Inter-Quartile Range | score on a scale | At Baseline, at 6 Weeks |
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| Secondary | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | 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. | Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit). | Posted | Count of Participants | Participants | At 6 Weeks |
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| Secondary | Average Frequency of Dressing Changes | 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. | Only 1 participant returned their survey for this outcome | Posted | Mean | Inter-Quartile Range | dressing changes per wound per day | 6 Weeks |
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| Secondary | Number of Participants Reporting Overall Dressing Preference for Specific Body Part | Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided. | Posted | Count of Participants | Participants | At Baseline |
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| Secondary | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Participant reported dressing preference for specific body parts for each of the interventions received. | Not all participants have wounds in all body parts noted (axilla, buttocks, groin, abdomen and breast). | Posted | Count of Participants | Participants | Visit 1 (Day 14) |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| Title | Measurements |
|---|
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| Moderate |
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| Severe |
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| Very Severe |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Groin |
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| Abdomen |
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| Breast/inframammary fold |
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