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

NCT06700850 | Completed Results

• 2 other identifiers: HVS2312CIV-24-03-046336
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. 1.Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee.
2. 2.Prototype dressing (square) vs Marketed dressing (square) on the thigh.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acceptable Dressing Presence at Day 7

  Count of participants with acceptable dressing presence was determined from 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 (rectangle) vs Marketed dressing (rectangle) on knees

OTHER

Each participant will receive a comparison pair Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair will be randomised to either the right or left knee in a 1:1 ratio.

Device: Prototype dressing rectangle; Device: Marketed dressing rectangle

Prototype dressing (square) vs Marketed dressing (square) on thighs

OTHER

Each participant will receive a comparison pair Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair will be randomised to either the right or left thigh in a 1:1 ratio.

Device: Prototype dressing square; Device: Marketed dressing square

Interventions

Prototype dressing rectangle DEVICE

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

Prototype dressing (rectangle) vs Marketed dressing (rectangle) on knees

Marketed dressing rectangle DEVICE

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

Prototype dressing (rectangle) vs Marketed dressing (rectangle) on knees

Prototype dressing square DEVICE

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

Prototype dressing (square) vs Marketed dressing (square) on thighs

Marketed dressing square DEVICE

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

Prototype dressing (square) vs Marketed dressing (square) on thighs

Eligibility Criteria

• Age: 22 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 22-70 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
• Footnote:
• \* 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 (0, 3, 5 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 and with respect to the physiotherapy session) 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

Limitations and Caveats

This was a clinical investigation to evaluate the performance of two prototype dressings in comparison to their respective comparator dressings. Only participants with healthy and intact skin at the test sites were included in the investigation and as such the test conditions do not try and replicate the use case conditions for wound management as the influence of a wound is not considered. As such the interpretation of the results should not be extended beyond the scope of this investigation.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

07811407089

Study Officials

• Kirstin Deuble-Bente

  SGS proderm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 8, 2024
• First Posted: November 22, 2024
• Study Start: October 28, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)