Trial Outcomes & Findings for Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin (NCT NCT06700850)
NCT ID: NCT06700850
Last Updated: 2026-04-02
Results Overview
Count of participants with acceptable dressing presence was determined from a yes/no assessment at day 7, with a 'yes' response defined as the dressing is in place with no border lift reaching the pad and no pad exposure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
Day 7
Results posted on
2026-04-02
Participant Flow
The enrollment period started on 28 October 2024 and ended on 09 January 2025. It required approximately 10 weeks to recruit all participants.
Prior to application of the four different dressings (two prototype and two marketed dressings), a physical skin assessment occurred to ensure skin was healthy, intact \& hair free. Upon eligibility confirmation, the investigator would apply the appropriate dressing to the randomized right/left knee (rectangle dressing) and right/left thigh (square dressing). All participants would receive all dressings (i.e., each participant is their own control with the comparator dressing).
Unit of analysis: dressings
Participant milestones
| Measure |
Intra-Individual Comparison of Two Prototype Wound Dressings
All participants received all four different dressings (two prototype dressings and two marketed dressings). The dressings were grouped by shape and applied to their designated application site via randomization to create two comparison pairs. Pair 1 consisted of the rectangle prototype dressing and rectangle marketed dressing applied to the randomized right/left knee on the participant. Pair 2 consisted of the square prototype dressing and square marketed dressing applied to the randomized right/left thigh on the same participant.
|
|---|---|
|
Overall Study
STARTED
|
135 540
|
|
Overall Study
Prototype Dressing (Rectangle) on Knee
|
135 135
|
|
Overall Study
Marketed Dressing (Rectangle) on Knee
|
135 135
|
|
Overall Study
Prototype Dressing (Square) on Thigh
|
135 135
|
|
Overall Study
Marketed Dressing (Square) on Thigh
|
135 135
|
|
Overall Study
COMPLETED
|
135 540
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intra-Individual Comparison of Two Prototype Wound Dressings
n=135 Participants
All participants received all four different dressings (two prototype dressings and two marketed dressings). The dressings were grouped by shape and applied to their designated application site via randomization to create two comparison pairs. Pair 1 consisted of the rectangle prototype dressing and rectangle marketed dressing applied to the randomized right/left knee on the participant. Pair 2 consisted of the square prototype dressing and square marketed dressing applied to the randomized right/left thigh on the same participant.
|
|---|---|
|
Age, Continuous
|
54.19 years
STANDARD_DEVIATION 11.29 • n=135 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=135 Participants
|
|
Region of Enrollment
Germany
|
135 participants
n=135 Participants
|
|
Height
|
167.33 centimeters (cm)
STANDARD_DEVIATION 8.31 • n=135 Participants
|
|
Weight
|
77.48 kilograms (kg)
STANDARD_DEVIATION 16.83 • n=135 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Full analysis set (FAS) included all participants of the Safety Population with at least one post baseline assessment.
Count of participants with acceptable dressing presence was determined from a yes/no assessment at day 7, with a 'yes' response defined as the dressing is in place with no border lift reaching the pad and no pad exposure.
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=135 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=135 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=135 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=135 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Number of Participants With Acceptable Dressing Presence at Day 7
No
|
48 Participants
|
23 Participants
|
35 Participants
|
27 Participants
|
|
Number of Participants With Acceptable Dressing Presence at Day 7
Yes
|
87 Participants
|
112 Participants
|
100 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 3Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Count of participants with an acceptable dressing presence was determined from a yes/no assessment at Day 1 and 3, with a 'yes' response defined as the dressing is in place with no border lift reaching the pad and no pad exposure.
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 3: Acceptable dressing presence · No
|
29 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 1: Acceptable dressing presence · No
|
16 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 1: Acceptable dressing presence · Yes
|
111 Participants
|
123 Participants
|
120 Participants
|
121 Participants
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 3: Acceptable dressing presence · Yes
|
98 Participants
|
115 Participants
|
113 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Dressing presence was measured by the count of participants at Day 1, 3 and 7 based on responses to the question "Is the dressing in place?" (yes/no).
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Presence of Dressing
Day 7: Is the dressing in place? · No
|
6 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
|
Presence of Dressing
Day 7: Is the dressing in place? · Yes
|
121 Participants
|
124 Participants
|
120 Participants
|
118 Participants
|
|
Presence of Dressing
Day 1: Is the dressing in place? · No
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Presence of Dressing
Day 1: Is the dressing in place? · Yes
|
127 Participants
|
127 Participants
|
126 Participants
|
125 Participants
|
|
Presence of Dressing
Day 3: Is the dressing in place? · No
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Presence of Dressing
Day 3: Is the dressing in place? · Yes
|
124 Participants
|
125 Participants
|
124 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Changes to the integrity of the dressing pad (e.g., bunching, folding, ridges) assessed at Day 1, 3 and 7 by count of participants categorized as one of the following: 1. 0% (no change) 2. 1-25% 3. 26%-50% 4. 51%-75% 5. 76-100% 6. Dressing missing
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Pad Integrity
Day 1: Pad integrity · 0% (no change)
|
119 Participants
|
125 Participants
|
123 Participants
|
122 Participants
|
|
Pad Integrity
Day 3: Pad integrity · 51%-75%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 1: Pad integrity · 1-25%
|
8 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Pad Integrity
Day 1: Pad integrity · 26%-50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 1: Pad integrity · 51%-75%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 1: Pad integrity · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 1: Pad integrity · Dressing missing
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Pad Integrity
Day 3: Pad integrity · 0% (no change)
|
112 Participants
|
120 Participants
|
120 Participants
|
121 Participants
|
|
Pad Integrity
Day 3: Pad integrity · 1-25%
|
9 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Pad Integrity
Day 3: Pad integrity · 26%-50%
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 3: Pad integrity · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 3: Pad integrity · Dressing missing
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Pad Integrity
Day 7: Pad integrity · 0% (no change)
|
82 Participants
|
108 Participants
|
94 Participants
|
101 Participants
|
|
Pad Integrity
Day 7: Pad integrity · 1-25%
|
35 Participants
|
13 Participants
|
22 Participants
|
15 Participants
|
|
Pad Integrity
Day 7: Pad integrity · 26%-50%
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Pad Integrity
Day 7: Pad integrity · 51%-75%
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Pad Integrity
Day 7: Pad integrity · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Integrity
Day 7: Pad integrity · Dressing missing
|
6 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Pad lift to determine the extent of pad area lifted and if it was no longer adhered to the participant's skin was identified at Day 1, 3 and 7. Lifting of the dressing pad was measured by the count of participants from one of the following percentage pad lift categories: 1. 0% (no lift) 2. 1-25% 3. 26%-50% 4. 51%-75% 5. 76-100% 6. Dressing missing
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Pad Lift
Day 3: Pad lift · 1-25%
|
21 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
|
Pad Lift
Day 3: Pad lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 3: Pad lift · 26%-50%
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Pad Lift
Day 3: Pad lift · 51%-75%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 3: Pad lift · Dressing missing
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Pad Lift
Day 7: Pad lift · 0% (no lift)
|
86 Participants
|
111 Participants
|
95 Participants
|
105 Participants
|
|
Pad Lift
Day 1: Pad lift · 0% (no lift)
|
113 Participants
|
123 Participants
|
121 Participants
|
121 Participants
|
|
Pad Lift
Day 1: Pad lift · 1-25%
|
13 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Pad Lift
Day 1: Pad lift · 26%-50%
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 1: Pad lift · 51%-75%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 1: Pad lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 1: Pad lift · Dressing missing
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Pad Lift
Day 3: Pad lift · 0% (no lift)
|
99 Participants
|
117 Participants
|
114 Participants
|
117 Participants
|
|
Pad Lift
Day 7: Pad lift · 1-25%
|
29 Participants
|
10 Participants
|
20 Participants
|
11 Participants
|
|
Pad Lift
Day 7: Pad lift · 26%-50%
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Pad Lift
Day 7: Pad lift · 51%-75%
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Pad Lift
Day 7: Pad lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pad Lift
Day 7: Pad lift · Dressing missing
|
6 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Border lift to determine the extent of border area lifted and if it was no longer adhered to the participant's skin was identified at Day 1, 3 and 7. Lifting of the dressing border was measured by the count of participants from one of the following percentage border lift categories: 1. 0% (no lift) 2. 1-25% 3. 26%-50% 4. 51%-75% 5. 76-100% 6. Dressing missing
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Border Lift
Day 3: Border lift · 51%-75%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Border Lift
Day 1: Border lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Border Lift
Day 1: Border lift · 0% (no lift)
|
36 Participants
|
63 Participants
|
66 Participants
|
74 Participants
|
|
Border Lift
Day 1: Border lift · 1-25%
|
87 Participants
|
62 Participants
|
57 Participants
|
47 Participants
|
|
Border Lift
Day 1: Border lift · 26%-50%
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Border Lift
Day 1: Border lift · 51%-75%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Border Lift
Day 1: Border lift · Dressing missing
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Border Lift
Day 3: Border lift · 0% (no lift)
|
20 Participants
|
40 Participants
|
32 Participants
|
41 Participants
|
|
Border Lift
Day 3: Border lift · 1-25%
|
100 Participants
|
82 Participants
|
90 Participants
|
79 Participants
|
|
Border Lift
Day 3: Border lift · 26%-50%
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Border Lift
Day 3: Border lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Border Lift
Day 3: Border lift · Dressing missing
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Border Lift
Day 7: Border lift · 0% (no lift)
|
7 Participants
|
17 Participants
|
3 Participants
|
11 Participants
|
|
Border Lift
Day 7: Border lift · 1-25%
|
107 Participants
|
103 Participants
|
106 Participants
|
102 Participants
|
|
Border Lift
Day 7: Border lift · 26%-50%
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Border Lift
Day 7: Border lift · 51%-75%
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Border Lift
Day 7: Border lift · 76-100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Border Lift
Day 7: Border lift · Dressing missing
|
6 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing).
Dressing comfort measured by the count of participants at Day 1, 3 and 7 from the participant's answer to the question "was the dressing comfortable during wear?" from one of the following responses: 1. No 2. Yes 3. Dressing missing
Outcome measures
| Measure |
Prototype Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle):
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=127 Participants
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle):
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square):
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=127 Participants
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square):
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · No
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · No
|
6 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · Yes
|
121 Participants
|
123 Participants
|
127 Participants
|
126 Participants
|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · Dressing missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · Yes
|
124 Participants
|
125 Participants
|
126 Participants
|
125 Participants
|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · Dressing missing
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · No
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · Yes
|
119 Participants
|
122 Participants
|
120 Participants
|
120 Participants
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · Dressing missing
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
All Participants: Systemic Events
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Prototype Dressing (Rectangle) on Knee
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Marketed Dressing (Rectangle) on Knee
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Prototype Dressing (Square) on Thigh
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Marketed Dressing (Square) on Thigh
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants: Systemic Events
n=135 participants at risk
All participants for events with no product relationship (i.e., unrelated to prototype or marketed dressings)
|
Prototype Dressing (Rectangle) on Knee
n=135 participants at risk
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location.
Prototype dressing (rectangle): Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
|
Marketed Dressing (Rectangle) on Knee
n=135 participants at risk
Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location.
Marketed dressing (rectangle): CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
|
Prototype Dressing (Square) on Thigh
n=135 participants at risk
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location.
Prototype dressing (square): Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
Marketed Dressing (Square) on Thigh
n=135 participants at risk
Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location.
Marketed dressing (square): CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching Sensation
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
2.2%
3/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
2.2%
3/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
1.5%
2/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
General disorders
Pain
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
5.2%
7/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
3.0%
4/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
1.5%
2/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Skin and subcutaneous tissue disorders
Skin Inflammation/ Irritation
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
1.5%
2/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Gastrointestinal disorders
Gastrointestinal Tract Infection
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
General disorders
Headache
|
2.2%
3/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Reproductive system and breast disorders
Period Cramps
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Musculoskeletal and connective tissue disorders
Fracture to little finger
|
0.74%
1/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/135 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator is employed by CRO: SGS proderm GmbH. The Study Protocol, section 21.3 states: Investigators may publish results generated from this clinical investigation, but not without prior agreement with, and review by, the sponsor, as detailed in the clinical study agreement between sponsor and CRO/investigator.
- Publication restrictions are in place
Restriction type: OTHER