NCT06831448

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

An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of a Prototype Multilayer Foam Dressing in Comparison to ALLEVYN◊ LIFE and Another Established Medical Device.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center prospective, open-label, comparative, interventional study with intra-individual comparison. Each participant will receive four dressings (two prototype dressings and one of each comparator Marketed dressings). The dressings will be randomized to either the left or right thigh/shin in a 1:1 ratio. Primary analyses will be performed on the following comparison pairs: 1. Prototype dressing vs Marketed dressing 1 on thighs and shins 2. Prototype dressing vs Marketed dressing 2 on thighs and shins 120 participants will be recruited into this study at a single, Germany-based site. The sample size accounts for the required 105 evaluable participants and approximately 10% lost to follow-up rate. Participants will be in good general health and have intact skin. Duration of the study will be 7-14 days, with participants attending 5 site visits. Screening can be completed on Day 0 or at a separate visit up to 7 days prior to Day 0. Dressings will be worn by participants for up to 7 days. A screening visit will be completed Day -7 to Day 0 to assess participant eligibility and to perform informed consent. Objective and subjective assessments during visits will evaluate dressing performance and conformability properties. On Day 0, dressings will be applied after appropriate skin assessments. On Day 1, 3 and 7, assessments will include acceptable dressing presence, retention, pad integrity, pad lift, border lift, and dressing comfort. On Day 7 or at dressing removal, additional assessments will include adhesive offset on skin, ease of removal and pain on removal. At each visit, photographs of the dressings will be taken. Furthermore, at each visit the skin at the application site will be assessed for any Adverse Events (AE) and the dressings assessed for Device Deficiencies.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2025-02-18
• Last updated: 2025-04-23

Locations

1 site across 1 country: Germany