Trial Outcomes & Findings for Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin. (NCT NCT06831448)
NCT ID: NCT06831448
Last Updated: 2026-06-09
Results Overview
Count of dressings with acceptable dressing presence was determined by 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.
COMPLETED
NA
120 participants
Day 7
2026-06-09
Participant Flow
The enrollment period started on 20 January 2025 and ended on 05 March 2025. It required approximately 6 weeks to recruit all participants.
Prior to application of 4 dressings composed of the 3 different dressing types (1 prototype dressing applied twice and 2 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 left or right thigh/shin so that a total of 4 dressings were applied.
Unit of analysis: dressings
Participant milestones
| Measure |
Intra-Individual Comparison of Prototype Dressing and Marketed Dressings
Each participant received all 3 available dressings applied to 4 locations (1 prototype dressing applied twice and 2 different marketed dressings). Randomization determined which dressing was applied to either the left or right thigh/shin location in a 1:1 ratio. All participants had 4 dressings applied in total (e.g., prototype dressing + marketed dressing 1 on the shins and prototype dressing + marketed dressing 2 on the thighs, or vice versa).
|
|---|---|
|
Overall Study
STARTED
|
120 480
|
|
Overall Study
Prototype dressing 1
|
120 240
|
|
Overall Study
Marketed dressing 1
|
120 120
|
|
Overall Study
Marketed dressing 2
|
120 120
|
|
Overall Study
COMPLETED
|
120 480
|
|
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 Prototype Dressing and Marketed Dressings
n=120 Participants
Each participant received all 3 available dressings applied to 4 locations (1 prototype dressing applied twice and 2 different marketed dressings). Randomization determined which dressing was applied to either the left or right thigh/shin location in a 1:1 ratio. All participants had 4 dressings applied in total (e.g., prototype dressing + marketed dressing 1 on the shins and prototype dressing + marketed dressing 2 on the thighs, or vice versa).
|
|---|---|
|
Age, Continuous
|
51.97 years
STANDARD_DEVIATION 13.47 • n=120 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=120 Participants
|
|
Height
|
169.69 centimeters (cm)
STANDARD_DEVIATION 8.72 • n=120 Participants
|
|
Weight
|
79.35 kilograms (kg)
STANDARD_DEVIATION 16.98 • n=120 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) population included all participants in the Safety population with at least one post baseline assessment.
Count of dressings with acceptable dressing presence was determined by 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
n=240 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=120 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=120 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Acceptable Dressing Presence at Day 7
Yes
|
175 dressings
|
100 dressings
|
78 dressings
|
|
Acceptable Dressing Presence at Day 7
No
|
65 dressings
|
20 dressings
|
42 dressings
|
SECONDARY outcome
Timeframe: Day 1 and Day 3Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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 dressings with acceptable dressing presence determined by 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
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 1: Acceptable dressing presence · No
|
15 dressings
|
4 dressings
|
11 dressings
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 1: Acceptable dressing presence · Yes
|
205 dressings
|
106 dressings
|
99 dressings
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 3: Acceptable dressing presence · No
|
33 dressings
|
10 dressings
|
25 dressings
|
|
Acceptable Dressing Presence at Day 1 and Day 3
Day 3: Acceptable dressing presence · Yes
|
187 dressings
|
100 dressings
|
85 dressings
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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 dressings at day 1, 3 and 7 based on responses to the question "Is the dressing in place?" (yes/no).
Outcome measures
| Measure |
Prototype Dressing
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Presence of Dressing
Day 1: Is the dressing in place? · No
|
1 dressings
|
1 dressings
|
3 dressings
|
|
Presence of Dressing
Day 1: Is the dressing in place? · Yes
|
219 dressings
|
109 dressings
|
107 dressings
|
|
Presence of Dressing
Day 3: Is the dressing in place? · Yes
|
217 dressings
|
109 dressings
|
105 dressings
|
|
Presence of Dressing
Day 7: Is the dressing in place? · No
|
11 dressings
|
6 dressings
|
10 dressings
|
|
Presence of Dressing
Day 7: Is the dressing in place? · Yes
|
209 dressings
|
104 dressings
|
100 dressings
|
|
Presence of Dressing
Day 3: Is the dressing in place? · No
|
3 dressings
|
1 dressings
|
5 dressings
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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 dressings categorized as one of the following percentage categories: 1. 0% (no change) 2. 1-25% 3. 26%-50% 4. 51%-75% 5. 76-100% 6. Dressing missing
Outcome measures
| Measure |
Prototype Dressing
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Pad Integrity
Day 7: Pad integrity · 0% (no change)
|
192 dressings
|
93 dressings
|
88 dressings
|
|
Pad Integrity
Day 7: Pad integrity · 1-25%
|
15 dressings
|
11 dressings
|
11 dressings
|
|
Pad Integrity
Day 7: Pad integrity · 26%-50%
|
2 dressings
|
0 dressings
|
1 dressings
|
|
Pad Integrity
Day 7: Pad integrity · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 7: Pad integrity · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 7: Pad integrity · Dressing missing
|
11 dressings
|
6 dressings
|
10 dressings
|
|
Pad Integrity
Day 1: Pad integrity · 0% (no change)
|
216 dressings
|
109 dressings
|
107 dressings
|
|
Pad Integrity
Day 1: Pad integrity · 1-25%
|
3 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 1: Pad integrity · 26%-50%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 1: Pad integrity · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 1: Pad integrity · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 1: Pad integrity · Dressing missing
|
1 dressings
|
1 dressings
|
3 dressings
|
|
Pad Integrity
Day 3: Pad integrity · 0% (no change)
|
211 dressings
|
107 dressings
|
104 dressings
|
|
Pad Integrity
Day 3: Pad integrity · 1-25%
|
6 dressings
|
2 dressings
|
1 dressings
|
|
Pad Integrity
Day 3: Pad integrity · 26%-50%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 3: Pad integrity · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 3: Pad integrity · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Integrity
Day 3: Pad integrity · Dressing missing
|
3 dressings
|
1 dressings
|
5 dressings
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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).
Lift of the dressing pad assessed at Day 1, 3 and 7 to determine the extent of pad area lifted and no longer adhered to the participant's skin by one of the following pad lift percentage 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
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Pad Lift
Day 7: Pad lift · 0% (no lift)
|
163 dressings
|
91 dressings
|
74 dressings
|
|
Pad Lift
Day 7: Pad lift · 1-25%
|
40 dressings
|
12 dressings
|
24 dressings
|
|
Pad Lift
Day 7: Pad lift · 26%-50%
|
5 dressings
|
1 dressings
|
2 dressings
|
|
Pad Lift
Day 7: Pad lift · 51%-75%
|
1 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 7: Pad lift · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 7: Pad lift · Dressing missing
|
11 dressings
|
6 dressings
|
10 dressings
|
|
Pad Lift
Day 1: Pad lift · 0% (no lift)
|
205 dressings
|
106 dressings
|
99 dressings
|
|
Pad Lift
Day 1: Pad lift · 1-25%
|
14 dressings
|
3 dressings
|
7 dressings
|
|
Pad Lift
Day 1: Pad lift · 26%-50%
|
0 dressings
|
0 dressings
|
1 dressings
|
|
Pad Lift
Day 1: Pad lift · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 1: Pad lift · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 1: Pad lift · Dressing missing
|
1 dressings
|
1 dressings
|
3 dressings
|
|
Pad Lift
Day 3: Pad lift · 0% (no lift)
|
187 dressings
|
100 dressings
|
85 dressings
|
|
Pad Lift
Day 3: Pad lift · 1-25%
|
28 dressings
|
8 dressings
|
20 dressings
|
|
Pad Lift
Day 3: Pad lift · 26%-50%
|
2 dressings
|
1 dressings
|
0 dressings
|
|
Pad Lift
Day 3: Pad lift · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 3: Pad lift · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Pad Lift
Day 3: Pad lift · Dressing missing
|
3 dressings
|
1 dressings
|
5 dressings
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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).
Lift of the dressing border assessed at Day 1, 3 and 7 to determine the extent of the border area lifted and no longer adhered to the participant's skin by one of the following border lift percentage 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
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Border Lift
Day 1: Border lift · 0% (no lift)
|
113 dressings
|
63 dressings
|
73 dressings
|
|
Border Lift
Day 1: Border lift · 26%-50%
|
0 dressings
|
1 dressings
|
1 dressings
|
|
Border Lift
Day 1: Border lift · 51%-75%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Border Lift
Day 3: Border lift · 26%-50%
|
1 dressings
|
2 dressings
|
1 dressings
|
|
Border Lift
Day 1: Border lift · 1-25%
|
106 dressings
|
45 dressings
|
33 dressings
|
|
Border Lift
Day 1: Border lift · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Border Lift
Day 1: Border lift · Dressing missing
|
1 dressings
|
1 dressings
|
3 dressings
|
|
Border Lift
Day 3: Border lift · 0% (no lift)
|
58 dressings
|
40 dressings
|
38 dressings
|
|
Border Lift
Day 3: Border lift · 1-25%
|
157 dressings
|
67 dressings
|
66 dressings
|
|
Border Lift
Day 3: Border lift · 51%-75%
|
1 dressings
|
0 dressings
|
0 dressings
|
|
Border Lift
Day 3: Border lift · 76-100%
|
0 dressings
|
0 dressings
|
0 dressings
|
|
Border Lift
Day 3: Border lift · Dressing missing
|
3 dressings
|
1 dressings
|
5 dressings
|
|
Border Lift
Day 7: Border lift · 0% (no lift)
|
45 dressings
|
26 dressings
|
22 dressings
|
|
Border Lift
Day 7: Border lift · 1-25%
|
144 dressings
|
71 dressings
|
70 dressings
|
|
Border Lift
Day 7: Border lift · 26%-50%
|
12 dressings
|
6 dressings
|
6 dressings
|
|
Border Lift
Day 7: Border lift · 51%-75%
|
6 dressings
|
1 dressings
|
1 dressings
|
|
Border Lift
Day 7: Border lift · 76-100%
|
2 dressings
|
0 dressings
|
1 dressings
|
|
Border Lift
Day 7: Border lift · Dressing missing
|
11 dressings
|
6 dressings
|
10 dressings
|
SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 7Population: The Per Protocol (PP) population included all participants in the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 10 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 assessed at Day 1, 3 and 7 by the participant's answer to the question "was the dressing comfortable during wear?" from one of the following responses: 1. Yes 2. No 3. Dressing missing
Outcome measures
| Measure |
Prototype Dressing
n=220 dressings
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=110 dressings
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=110 dressings
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · Dressing missing
|
0 dressings
|
1 dressings
|
3 dressings
|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · Yes
|
214 dressings
|
105 dressings
|
104 dressings
|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · No
|
3 dressings
|
4 dressings
|
1 dressings
|
|
Dressing Comfort
Day 3: Was the dressing comfortable during wear? · Dressing missing
|
3 dressings
|
1 dressings
|
5 dressings
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · Yes
|
209 dressings
|
104 dressings
|
98 dressings
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · No
|
2 dressings
|
1 dressings
|
2 dressings
|
|
Dressing Comfort
Day 7: Was the dressing comfortable during wear? · Dressing missing
|
9 dressings
|
5 dressings
|
10 dressings
|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · Yes
|
217 dressings
|
106 dressings
|
106 dressings
|
|
Dressing Comfort
Day 1: Was the dressing comfortable during wear? · No
|
3 dressings
|
3 dressings
|
1 dressings
|
Adverse Events
All Participants: Systemic Events
Prototype Dressing
Marketed Dressing 1
Marketed Dressing 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants: Systemic Events
n=120 participants at risk
All participants for events with no product relationship (i.e., unrelated to prototype or marketed dressings)
|
Prototype Dressing
n=120 participants at risk
Prototype dressing applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 1
n=120 participants at risk
Marketed dressing 1 applied on the left or right thigh/shin in a 1:1 ratio.
|
Marketed Dressing 2
n=120 participants at risk
Marketed dressing 2 applied on the left or right thigh/shin in a 1:1 ratio.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
2.5%
3/120 • Number of events 4 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Skin and subcutaneous tissue disorders
Itching Sensation
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
10.0%
12/120 • Number of events 15 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
5.8%
7/120 • Number of events 7 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
5.8%
7/120 • Number of events 7 • 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%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Cold (sniffles)
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
|
Respiratory, thoracic and mediastinal disorders
Common cold: cough, sniffle
|
0.83%
1/120 • Number of events 1 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
0.00%
0/120 • Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
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