Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin. (NCT06831448) | Clinical Trial Compass
CompletedNot Applicable
Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin.
Germany120 participantsStarted 2025-01-27
Plain-language summary
The purpose of this study is to evaluate a new prototype multilayer foam dressing on healthy, intact skin.
The study will find out how well the new prototype dressing stays in place as well as other dressing performance and safety factors when compared to two corresponding, marketed dressings with a similar intended use profile and shape.
The study will compare:
1. Prototype dressing vs Marketed dressing 1 on thighs and shins.
2. Prototype dressing vs Marketed dressing 2 on thighs and shins.
The main aim of the study is to show that the new prototype dressing is 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participant is capable of providing informed consent
✓. Participant is willing and able to make all required study visits
✓. Aged 18-70 years at the time of signing the informed consent\*
✓. Participant must be in good health, as determined by the Investigator, based on medical evaluation, including medical history and skin application site assessment (healthy intact skin at or near any of the dressing application sites)
✓. Participant is willing not to use cosmetic or medicinal lotions, creams, ointments and anything else which may interfere with dressing adhesion at dressing application sites for the duration of the study from 24 hours before dressing application on Day 0.
✓. Participant is willing to have excess hair removed from the dressing application sites
✓. Participant is willing to avoid immersing the dressings in water (no swimming or bathing) for the duration of the study
Exclusion criteria
✕. Female participant who is pregnant, or lactating.
✕. Participant has a known sensitivity to any of the study products, materials or ancillary product or components.
✕. Known skin sensitivity or allergies to adhesives, skin wipes, soap, surgical first-aid dressings, natural rubber or rubber latex, etc.
✕. Participants with a current active skin disease (e.g., eczema, psoriasis, or severe dermatoporosis), sunburn or skin peeling at the dressing application sites.
✕. Participants with a medical condition which may interfere with their perception of pain (such as diabetes, small-fibre neuropathy, allodynia, hyperalgesia etc.).
✕. Heavy smokers (e.g. \>20 cigarettes (\~1 pack) a day over the last 10 years) whose pain perception may have been affected through smoking.
✕. Participants with any skin features near any of the dressing application sites that could be identifiable/may interfere with skin assessments (e.g. tattoos/distinctive markings or scars/keloids).
✕. Participants diagnosed with hyperhidrosis or who self-report their normal sweating level to be severe as determined by the Sweating Severity Self-Assessment (SSSA) at screening (e.g. mild, moderate, severe).