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

NCT06831448 | Completed

• 2 other identifiers: HVS2313CIV-24-02-046076
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.Prototype dressing vs Marketed dressing 1 on thighs and shins.
2. 2.Prototype dressing vs Marketed dressing 2 on thighs and shins.

Conditions

Healthy

Keywords

Foam dressing; healthy volunteers; intact skin; wear-time

Outcome Measures

Primary Outcomes (1)

• Acceptable Dressing Presence at Day 7

  Acceptable dressing presence determined by 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.

  Day 7

Secondary Outcomes (6)

• Acceptable Dressing Presence at Day 1 and Day 3

  Day 1 and Day 3

• Presence of Dressing

  Day 1, Day 3 and Day 7

• Pad Integrity

  Day 1, Day 3 and Day 7

• Pad Lift

  Day 1, Day 3 and Day 7

• Border Lift

  Day 1, Day 3 and Day 7

Study Arms (2)

Prototype dressing vs Marketed dressing 1

OTHER

The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 1 on the left or right thigh/shin in a 1:1 ratio.

Device: Prototype dressing; Device: Marketed dressing 1

Prototype dressing vs Marketed dressing 2

OTHER

The participant will be randomised to receive the comparison pair Prototype dressing vs Marketed dressing 2 on the left or right thigh/shin in a 1:1 ratio.

Device: Prototype dressing; Device: Marketed dressing 2

Interventions

Prototype dressing DEVICE

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

Prototype dressing vs Marketed dressing 1; Prototype dressing vs Marketed dressing 2

Marketed dressing 1 DEVICE

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.

Prototype dressing vs Marketed dressing 1

Marketed dressing 2 DEVICE

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

Prototype dressing vs Marketed dressing 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \[\*at least 10% of participants are aged \>55 years\]

You may not qualify if:

• 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).
• Participants not willing to refrain from the use of pain relief medication on assessment days (1, 3 and 7) and in the case of certain medications, 24 hours before assessments.
• Participants unwilling to refrain from activities which may directly affect the dressing, dressing application sites or assessments (such as undergoing planned scanning procedures, e.g., X-ray, magnetic resonance imaging (MRI) and computed tomography (CT) scanning; exposure to airport scanners or devices emitting radio waves; exposure to atypical conditions of pressure, humidity and temperature; immersing the dressing in water e.g. bathing / swimming / cleaning the dressing application sites; using a sauna; undertaking strenuous physical activity like aerobics, running, cycling, heavy labor etc.; using lotions/creams/ointments etc. at the dressing application sites; excessively exposing the dressing application sites to the sun (e.g. sunbathing for \>1 hour); wearing tightly fitting clothes which could affect the dressings.
• Individuals who have participated in a clinical study in the last 7 days, using the same dressing application sites.
• Participants with poor compliance and / or poor willingness to co-operate.
• Individuals who should not participate in the clinical investigation for any other reason (including the taking of certain medications) as judged by the Investigator.
• Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).
• Employees of the investigation sites directly involved in this clinical investigation or employees of the sponsor's company.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

SGS Proderm

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Study Officials

• Kirstin Deuble-Bente

  SGS proderm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: January 27, 2025
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)