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Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin.

NCT06831448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

Prototype dressing

Five-layer foam dressing with polyurethane, cellulose, bicomponent, superabsorbent polymer, silicone adhesive, acrylic adhesive. LDPE. Size: 10cm x 10 cm. Topical application. Single use.

DEVICE

Marketed dressing 1

Five-layer foam dressing with polyurethane, polyethylene, cellulose, bicomponent, superabsorbent polymer, silicone adhesive, acrylic adhesive, polypropylene. Size: 12.9cm × 12.9cm. Topical application. Single use.

DEVICE

Marketed dressing 2

Five-layer foam dressing with silicone, polyurethane, polyacrylate, cotton, viscose, polyester and polyolefin. Size: 10cm x 10 cm. Topical application. Single use.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Kirstin Deuble-Bente · SGS proderm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2025-03-17
Completion
2025-03-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831448 on ClinicalTrials.gov