Trial Outcomes & Findings for Wound Dressings for Hidradenitis Suppurativa (NCT NCT04194541)
NCT ID: NCT04194541
Last Updated: 2023-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
At Baseline, at 6 Weeks
Results posted on
2023-03-14
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Visit 0 (Baseline)
STARTED
|
28
|
|
Visit 0 (Baseline)
COMPLETED
|
28
|
|
Visit 0 (Baseline)
NOT COMPLETED
|
0
|
|
Day 1 Through 13
STARTED
|
28
|
|
Day 1 Through 13
COMPLETED
|
19
|
|
Day 1 Through 13
NOT COMPLETED
|
9
|
|
Visit 1 (Day 14)
STARTED
|
19
|
|
Visit 1 (Day 14)
COMPLETED
|
19
|
|
Visit 1 (Day 14)
NOT COMPLETED
|
0
|
|
Day 15 Through Week 6
STARTED
|
19
|
|
Day 15 Through Week 6
COMPLETED
|
14
|
|
Day 15 Through Week 6
NOT COMPLETED
|
5
|
|
Visit 2 (6 Weeks)
STARTED
|
14
|
|
Visit 2 (6 Weeks)
COMPLETED
|
14
|
|
Visit 2 (6 Weeks)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Day 1 Through 13
Lost to Follow-up
|
3
|
|
Day 1 Through 13
Coronavirus Disease of 2019 (COVID-19) shut down
|
6
|
|
Day 15 Through Week 6
Lost to Follow-up
|
5
|
Baseline Characteristics
Wound Dressings for Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Treatment Group
n=28 Participants
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.
|
|---|---|
|
Age, Continuous
|
34.57 years
STANDARD_DEVIATION 12.49 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Dermatology Life Quality Index (DLQI) Scores
Visit 0 (Baseline)
|
15.5 score on a scale
Interval 11.0 to 24.0
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Scores
Visit 2 (Week 6)
|
12.5 score on a scale
Interval 7.8 to 15.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Visit 0 (Baseline)
|
6.5 score on a scale
Interval 3.0 to 7.5
|
—
|
—
|
|
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Visit 2 (week 6)
|
5 score on a scale
Interval 2.75 to 7.25
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Visit 0 (Baseline)
|
7.5 score on a scale
Interval 3.5 to 8.0
|
—
|
—
|
|
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Visit 2 (Week 6)
|
6.5 score on a scale
Interval 2.75 to 7.25
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Sleep Rating
Visit 2 (Week 6)
|
3.5 score on a scale
Interval 1.75 to 3.5
|
—
|
—
|
|
Sleep Rating
Visit 0 (Baseline)
|
4 score on a scale
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Drainage Rating
Visit 0 (Baseline)
|
3.06 score on a scale
Interval 3.0 to 4.0
|
—
|
—
|
|
Drainage Rating
Visit 2 (Week 6)
|
3.6 score on a scale
Interval 3.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, at 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Odor Rating
Visit 0 (Baseline)
|
2.5 score on a scale
Interval 2.0 to 3.0
|
—
|
—
|
|
Odor Rating
Visit 2 (Week 6)
|
2.5 score on a scale
Interval 2.0 to 3.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 WeeksPopulation: Data is representative of the 14 participants that completed the study per protocol (completed Week 6 visit).
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.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Clear
|
0 Participants
|
—
|
—
|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Minimal
|
0 Participants
|
—
|
—
|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Mild
|
0 Participants
|
—
|
—
|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Moderate
|
10 Participants
|
—
|
—
|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Severe
|
3 Participants
|
—
|
—
|
|
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Very Severe
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: Only 1 participant returned their survey for this outcome
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.
Outcome measures
| Measure |
Treatment Group
n=1 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Average Frequency of Dressing Changes
|
1 dressing changes per wound per day
Interval 1.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At BaselineOverall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.
Outcome measures
| Measure |
Treatment Group
n=28 Participants
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.
|
Cutimed Siltect
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Cutimed Sorbact Hydroactive B Wound Dressing
|
9 Participants
|
—
|
—
|
|
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Cutimed Siltect Wound Dressing
|
13 Participants
|
—
|
—
|
|
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Sorbion Sana Multi-star Wound Dressing
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (Day 14)Population: Not all participants have wounds in all body parts noted (axilla, buttocks, groin, abdomen and breast).
Participant reported dressing preference for specific body parts for each of the interventions received.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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.
|
Cutimed Siltect
n=19 Participants
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
Sorbion Sana Multi-Star
n=19 Participants
All participants received all three interventions (Cutimed Sorbact Hydroactive B, Cutimed Siltect and Sorbion Sana Multi-Star)
|
|---|---|---|---|
|
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Axilla
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Buttocks/gluteal fold
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Groin
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Abdomen
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Breast/inframammary fold
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place