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NCT06700850

Human Participant Study of Prototype Non-medicated Multilayer Foam Dressings on Intact Skin

Completed NA Results posted Last updated 2 April 2026
What this trial tests

NA trial testing Prototype dressing rectangle in Healthy in 135 participants. Completed in 21 January 2025.

Timeline
28 October 2024
Primary endpoint
21 January 2025
21 January 2025

Quick facts

Lead sponsorSmith & Nephew, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment135
Start date28 October 2024
Primary completion21 January 2025
Estimated completion21 January 2025
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Smith & Nephew, Inc. — full company profile →

Who can join

Adults 22 to 70, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Acceptable Dressing Presence at Day 7 Primary · Day 7

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.

GroupValue95% CI
Prototype Dressing (Rectangle) on Knee48
Marketed Dressing (Rectangle) on Knee23
Prototype Dressing (Square) on Thigh35
Marketed Dressing (Square) on Thigh27
Prototype Dressing (Rectangle) on Knee87
Marketed Dressing (Rectangle) on Knee112
Prototype Dressing (Square) on Thigh100
Marketed Dressing (Square) on Thigh108
Acceptable Dressing Presence at Day 1 and Day 3 Secondary · Day 1 and Day 3

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.

Day 1: Acceptable dressing presence
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee16
Marketed Dressing (Rectangle) on Knee4
Prototype Dressing (Square) on Thigh7
Marketed Dressing (Square) on Thigh6
Prototype Dressing (Rectangle) on Knee111
Marketed Dressing (Rectangle) on Knee123
Prototype Dressing (Square) on Thigh120
Marketed Dressing (Square) on Thigh121
Day 3: Acceptable dressing presence
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee29
Marketed Dressing (Rectangle) on Knee12
Prototype Dressing (Square) on Thigh14
Marketed Dressing (Square) on Thigh11
Prototype Dressing (Rectangle) on Knee98
Marketed Dressing (Rectangle) on Knee115
Prototype Dressing (Square) on Thigh113
Marketed Dressing (Square) on Thigh116
Presence of Dressing Secondary · Day 1, Day 3 and Day 7

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).

Day 1: Is the dressing in place?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh2
Prototype Dressing (Rectangle) on Knee127
Marketed Dressing (Rectangle) on Knee127
Prototype Dressing (Square) on Thigh126
Marketed Dressing (Square) on Thigh125
Day 3: Is the dressing in place?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee3
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh5
Prototype Dressing (Rectangle) on Knee124
Marketed Dressing (Rectangle) on Knee125
Prototype Dressing (Square) on Thigh124
Marketed Dressing (Square) on Thigh122
Day 7: Is the dressing in place?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee6
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh7
Marketed Dressing (Square) on Thigh9
Prototype Dressing (Rectangle) on Knee121
Marketed Dressing (Rectangle) on Knee124
Prototype Dressing (Square) on Thigh120
Marketed Dressing (Square) on Thigh118
Pad Integrity Secondary · Day 1, Day 3 and Day 7

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

Day 1: Pad integrity
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee119
Marketed Dressing (Rectangle) on Knee125
Prototype Dressing (Square) on Thigh123
Marketed Dressing (Square) on Thigh122
Prototype Dressing (Rectangle) on Knee8
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh3
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Day 3: Pad integrity
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee112
Marketed Dressing (Rectangle) on Knee120
Prototype Dressing (Square) on Thigh120
Marketed Dressing (Square) on Thigh121
Prototype Dressing (Rectangle) on Knee9
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh4
Marketed Dressing (Square) on Thigh1
Prototype Dressing (Rectangle) on Knee3
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Day 7: Pad integrity
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee82
Marketed Dressing (Rectangle) on Knee108
Prototype Dressing (Square) on Thigh94
Marketed Dressing (Square) on Thigh101
Prototype Dressing (Rectangle) on Knee35
Marketed Dressing (Rectangle) on Knee13
Prototype Dressing (Square) on Thigh22
Marketed Dressing (Square) on Thigh15
Prototype Dressing (Rectangle) on Knee3
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh1
Prototype Dressing (Rectangle) on Knee1
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh1
Pad Lift Secondary · Day 1, Day 3 and Day 7

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

Day 1: Pad lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee113
Marketed Dressing (Rectangle) on Knee123
Prototype Dressing (Square) on Thigh121
Marketed Dressing (Square) on Thigh121
Prototype Dressing (Rectangle) on Knee13
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh5
Marketed Dressing (Square) on Thigh4
Prototype Dressing (Rectangle) on Knee1
Marketed Dressing (Rectangle) on Knee1
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Day 3: Pad lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee99
Marketed Dressing (Rectangle) on Knee117
Prototype Dressing (Square) on Thigh114
Marketed Dressing (Square) on Thigh117
Prototype Dressing (Rectangle) on Knee21
Marketed Dressing (Rectangle) on Knee5
Prototype Dressing (Square) on Thigh9
Marketed Dressing (Square) on Thigh5
Prototype Dressing (Rectangle) on Knee4
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Day 7: Pad lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee86
Marketed Dressing (Rectangle) on Knee111
Prototype Dressing (Square) on Thigh95
Marketed Dressing (Square) on Thigh105
Prototype Dressing (Rectangle) on Knee29
Marketed Dressing (Rectangle) on Knee10
Prototype Dressing (Square) on Thigh20
Marketed Dressing (Square) on Thigh11
Prototype Dressing (Rectangle) on Knee5
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh2
Marketed Dressing (Square) on Thigh2
Prototype Dressing (Rectangle) on Knee1
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh0
Border Lift Secondary · Day 1, Day 3 and Day 7

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

Day 1: Border lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee36
Marketed Dressing (Rectangle) on Knee63
Prototype Dressing (Square) on Thigh66
Marketed Dressing (Square) on Thigh74
Prototype Dressing (Rectangle) on Knee87
Marketed Dressing (Rectangle) on Knee62
Prototype Dressing (Square) on Thigh57
Marketed Dressing (Square) on Thigh47
Prototype Dressing (Rectangle) on Knee4
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh4
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Day 3: Border lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee20
Marketed Dressing (Rectangle) on Knee40
Prototype Dressing (Square) on Thigh32
Marketed Dressing (Square) on Thigh41
Prototype Dressing (Rectangle) on Knee100
Marketed Dressing (Rectangle) on Knee82
Prototype Dressing (Square) on Thigh90
Marketed Dressing (Square) on Thigh79
Prototype Dressing (Rectangle) on Knee4
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh1
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh0
Day 7: Border lift
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee7
Marketed Dressing (Rectangle) on Knee17
Prototype Dressing (Square) on Thigh3
Marketed Dressing (Square) on Thigh11
Prototype Dressing (Rectangle) on Knee107
Marketed Dressing (Rectangle) on Knee103
Prototype Dressing (Square) on Thigh106
Marketed Dressing (Square) on Thigh102
Prototype Dressing (Rectangle) on Knee5
Marketed Dressing (Rectangle) on Knee4
Prototype Dressing (Square) on Thigh6
Marketed Dressing (Square) on Thigh4
Prototype Dressing (Rectangle) on Knee2
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh5
Marketed Dressing (Square) on Thigh1
Dressing Comfort Secondary · Day 1, Day 3 and Day 7

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

Day 1: Was the dressing comfortable during wear?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee6
Marketed Dressing (Rectangle) on Knee4
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee121
Marketed Dressing (Rectangle) on Knee123
Prototype Dressing (Square) on Thigh127
Marketed Dressing (Square) on Thigh126
Prototype Dressing (Rectangle) on Knee0
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh1
Day 3: Was the dressing comfortable during wear?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee2
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh0
Marketed Dressing (Square) on Thigh0
Prototype Dressing (Rectangle) on Knee124
Marketed Dressing (Rectangle) on Knee125
Prototype Dressing (Square) on Thigh126
Marketed Dressing (Square) on Thigh125
Prototype Dressing (Rectangle) on Knee1
Marketed Dressing (Rectangle) on Knee0
Prototype Dressing (Square) on Thigh1
Marketed Dressing (Square) on Thigh2
Day 7: Was the dressing comfortable during wear?
GroupValue95% CI
Prototype Dressing (Rectangle) on Knee5
Marketed Dressing (Rectangle) on Knee3
Prototype Dressing (Square) on Thigh2
Marketed Dressing (Square) on Thigh1
Prototype Dressing (Rectangle) on Knee119
Marketed Dressing (Rectangle) on Knee122
Prototype Dressing (Square) on Thigh120
Marketed Dressing (Square) on Thigh120
Prototype Dressing (Rectangle) on Knee3
Marketed Dressing (Rectangle) on Knee2
Prototype Dressing (Square) on Thigh5
Marketed Dressing (Square) on Thigh6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants: Systemic Events
Serious: 0/135 (0%)
Deaths: 0/135
Prototype Dressing (Rectangle) on Knee
Serious: 0/135 (0%)
Deaths: 0/135
Marketed Dressing (Rectangle) on Knee
Serious: 0/135 (0%)
Deaths: 0/135
Prototype Dressing (Square) on Thigh
Serious: 0/135 (0%)
Deaths: 0/135
Marketed Dressing (Square) on Thigh
Serious: 0/135 (0%)
Deaths: 0/135
Other adverse events (9 terms — click to expand)

ReactionSystemAll Participants: Systemic…Prototype Dressing (Rectan…Marketed Dressing (Rectang…Prototype Dressing (Square…Marketed Dressing (Square)…
PainGeneral disorders
Itching SensationSkin and subcutaneous tissue disorders
HeadacheGeneral disorders
Skin Inflammation/ IrritationSkin and subcutaneous tissue disorders
Skin DiscolorationSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders
Gastrointestinal Tract InfectionGastrointestinal disorders
Period CrampsReproductive system and breast disorders
Fracture to little fingerMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT06700850 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate two new prototype non-medicated multilayer foam dressings on healthy, intact skin. The study will find out how well two new prototype dressings stay in place as well as other dressing performance and safety factors when compared to corresponding, marketed dressings with a similar intended use profile and shape. The study will compare: 1. Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee. 2. Prototype dressing (square) vs Marketed dressing (square) on the thigh. The main aim of the study is to show that the new prototype dressings are not worse than the established marketed comparison dressings in terms of staying in place on human participants at 7 days. Dressings will have successfully stayed in place if the dressing edges have not lifted to reach the pad, and the pad is not exposed in any way. Additional data will be collected to further support product performance up to 7 days, including safety information and potential device issues.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06700850.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing