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

NCT06700850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-02

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DEVICE

Prototype dressing rectangle

Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.

DEVICE

Marketed dressing rectangle

CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use

DEVICE

Prototype dressing square

Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.

DEVICE

Marketed dressing square

CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. 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
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-01-21
Completion
2025-01-21

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 NCT06700850 on ClinicalTrials.gov