Hidradenitis Suppurativa
Conditions
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).
Interventions
DEVICECutimed Sorbact Hydroactive B wound dressing
Wound dressing applied and changed as needed.
DEVICECutimed Siltect wound dressing
Wound dressing applied and changed as needed.
DEVICESorbion Sana multi-star wound dressing
Wound dressing applied and changed as needed.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Day 15 Through Week 6 | Lost to Follow-up | 5 |
| Day 1 Through 13 | Coronavirus Disease of 2019 (COVID-19) shut down | 6 |
| Day 1 Through 13 | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 34.57 years STANDARD_DEVIATION 12.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Dermatology Life Quality Index (DLQI) Scores | Visit 0 (Baseline) | 15.5 score on a scale |
| Treatment Group | Dermatology Life Quality Index (DLQI) Scores | Visit 2 (Week 6) | 12.5 score on a scale |
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.
Time frame: 6 Weeks
Population: Only 1 participant returned their survey for this outcome
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Average Frequency of Dressing Changes | 1 dressing changes per wound per day |
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Average Pain as Assessed by the Numerical Rating Scale (NRS) | Visit 0 (Baseline) | 6.5 score on a scale |
| Treatment Group | Average Pain as Assessed by the Numerical Rating Scale (NRS) | Visit 2 (week 6) | 5 score on a scale |
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment Group | Drainage Rating | Visit 0 (Baseline) | 3.06 score on a scale |
| Treatment Group | Drainage Rating | Visit 2 (Week 6) | 3.6 score on a scale |
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Maximal Pain as Assessed by the Numerical Rating Scale (NRS) | Visit 0 (Baseline) | 7.5 score on a scale |
| Treatment Group | Maximal Pain as Assessed by the Numerical Rating Scale (NRS) | Visit 2 (Week 6) | 6.5 score on a scale |
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.
Time frame: At 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Clear | 0 Participants |
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Minimal | 0 Participants |
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Mild | 0 Participants |
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Moderate | 10 Participants |
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Severe | 3 Participants |
| Treatment Group | Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading | Very Severe | 1 Participants |
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.
Time frame: Visit 1 (Day 14)
Population: Not all participants have wounds in all body parts noted (axilla, buttocks, groin, abdomen and breast).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Abdomen | 1 Participants |
| Treatment Group | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Groin | 2 Participants |
| Treatment Group | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Axilla | 7 Participants |
| Treatment Group | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Buttocks/gluteal fold | 1 Participants |
| Treatment Group | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Breast/inframammary fold | 0 Participants |
| Cutimed Siltect | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Groin | 1 Participants |
| Cutimed Siltect | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Axilla | 8 Participants |
| Cutimed Siltect | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Buttocks/gluteal fold | 3 Participants |
| Cutimed Siltect | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Abdomen | 2 Participants |
| Cutimed Siltect | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Breast/inframammary fold | 1 Participants |
| Sorbion Sana Multi-Star | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Breast/inframammary fold | 0 Participants |
| Sorbion Sana Multi-Star | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Abdomen | 0 Participants |
| Sorbion Sana Multi-Star | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Axilla | 4 Participants |
| Sorbion Sana Multi-Star | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Groin | 1 Participants |
| Sorbion Sana Multi-Star | Number of Participants Reporting Dressing Preference for Each Specific Body Part | Buttocks/gluteal fold | 2 Participants |
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.
Time frame: At Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Number of Participants Reporting Overall Dressing Preference for Specific Body Part | Cutimed Sorbact Hydroactive B Wound Dressing | 9 Participants |
| Treatment Group | Number of Participants Reporting Overall Dressing Preference for Specific Body Part | Cutimed Siltect Wound Dressing | 13 Participants |
| Treatment Group | Number of Participants Reporting Overall Dressing Preference for Specific Body Part | Sorbion Sana Multi-star Wound Dressing | 6 Participants |
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Odor Rating | Visit 0 (Baseline) | 2.5 score on a scale |
| Treatment Group | Odor Rating | Visit 2 (Week 6) | 2.5 score on a scale |
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.
Time frame: At Baseline, at 6 Weeks
Population: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Sleep Rating | Visit 0 (Baseline) | 4 score on a scale |
| Treatment Group | Sleep Rating | Visit 2 (Week 6) | 3.5 score on a scale |