HealthyNCT06700850

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

A study testing Prototype dressing rectangle, Marketed dressing rectangle and Prototype dressing square in people with Healthy, run by Smith & Nephew, Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 22 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Prototype dressing rectangle, Marketed dressing rectangle and Prototype dressing square
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 1 siteGermany
Study dates: 28 Oct 2024to 21 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

SGS proderm
Schenefeld, Schleswig-Holstein, 22869

Other trials in Germany

About this study

Official title: An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of Prototype Non-medicated Multilayer Foam Dressings Compared to Established Medical Devices

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:

Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee.
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.

Read the detailed description

This is a single-centre, prospective, open-label, comparative, interventional study with intra-individual comparison.

Four different dressings (two prototype investigational medical devices (IMDs) and two comparators) will be investigated, with each participant receiving all dressings. The dressings will be divided into two comparison pairs:

(i) Prototype dressing (rectangle) vs Marketed dressing (rectangle) (ii) Prototype dressing (square) vs Marketed dressing (square)

Comparison pair (i) will be applied to the knees (one dressing per knee) and comparison pair (ii) will be applied to the thighs (one dressing per thigh). The two dressing in each comparison pair will be randomised to either the right or left knee / thigh in a 1:1 ratio.

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 1, the assessments will be performed before and after a physiotherapy regime to evaluate dressing performance following mobilization of the leg/knee joint. 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
Being tested: Prototype dressing rectangle, Marketed dressing rectangle, Prototype dressing square, Marketed dressing square
Keywords: Foam dressing, healthy volunteers, intact skin, wear-time

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prototype dressing rectangleDevice
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
Marketed dressing rectangleDevice
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
Prototype dressing squareDevice
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
Marketed dressing squareDevice
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.

Study groups in NCT06700850
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Prototype dressing square; Device: Marketed dressing square

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 7

Secondary outcomes (6)

Acceptable Dressing Presence at Day 1 and Day 3
Count of participants with an acceptable dressing presence was determined from a yes/no assessment at Day 1 and 3, with a 'yes' response defined as the dressing is in place with no border lift reaching the pad and no pad exposure.
Measured: Day 1 and Day 3
Presence of Dressing
Dressing presence was measured by the count of participants at Day 1, 3 and 7 based on responses to the question "Is the dressing in place?" (yes/no).
Measured: Day 1, Day 3 and Day 7
Pad Integrity
Changes to the integrity of the dressing pad (e.g., bunching, folding, ridges) assessed at Day 1, 3 and 7 by count of participants categorized as one of the following:
1. 0% (no change)
2. 1-25%
3. 26%-50%
4. 51%-75%
5. 76-100%
6. Dressing missing
Measured: Day 1, Day 3 and Day 7
Pad Lift
Pad lift to determine the extent of pad area lifted and if it was no longer adhered to the participant's skin was identified at Day 1, 3 and 7. Lifting of the dressing pad was measured by the count of participants from one of the following percentage pad lift categories:
1. 0% (no lift)
2. 1-25%
3. 26%-50%
4. 51%-75%
5. 76-100%
6. Dressing missing
Measured: Day 1, Day 3 and Day 7
Border Lift
Border lift to determine the extent of border area lifted and if it was no longer adhered to the participant's skin was identified at Day 1, 3 and 7. Lifting of the dressing border was measured by the count of participants from one of the following percentage border lift categories:
1. 0% (no lift)
2. 1-25%
3. 26%-50%
4. 51%-75%
5. 76-100%
6. Dressing missing
Measured: Day 1, Day 3 and Day 7
Dressing Comfort
Dressing comfort measured by the count of participants at Day 1, 3 and 7 from the participant's answer to the question "was the dressing comfortable during wear?" from one of the following responses:
1. No
2. Yes
3. Dressing missing
Measured: Day 1, Day 3 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202421 Jan 2025

First posted22 Nov 2024
Study start28 Oct 2024
Primary completion21 Jan 2025
Study completion21 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06700850
Sponsor's protocol ID: HVS2312
Other IDs: CIV-24-03-046336
Status last verified: Nov 2024
First submitted: 8 Nov 2024
Last updated: 2 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of Prototype Non-medicated Multilayer Foam Dressings Compared to Established Medical Devices
ClinicalTrials.gov ID: NCT06700850
Acronym / sponsor ID: HVS2312
Conditions: Healthy
Keywords: Foam dressing, healthy volunteers, intact skin, wear-time
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 28 Oct 2024 (actual)
Primary completion: 21 Jan 2025 (actual)
Study completion: 21 Jan 2025 (actual)
First posted: 22 Nov 2024 (actual)
Results: Posted 2 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate two new prototype non-medicated multilayer foam dressings on healthy, intact skin.

The study will compare:

Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee.
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.

Detailed description

This is a single-centre, prospective, open-label, comparative, interventional study with intra-individual comparison.

(i) Prototype dressing (rectangle) vs Marketed dressing (rectangle) (ii) Prototype dressing (square) vs Marketed dressing (square)

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prototype dressing (rectangle) vs Marketed dressing (rectangle) on knees	Other	Device: Prototype dressing rectangle, Device: Marketed dressing rectangleEach 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.
Prototype dressing (square) vs Marketed dressing (square) on thighs	Other	Device: Prototype dressing square, Device: Marketed dressing squareEach 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.

Who may qualify

Ages: 22 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (15 listed)

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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prototype dressing rectanglePrototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.	Device	Prototype dressing (rectangle) vs Marketed dressing (rectangle) on knees
Marketed dressing rectangleCE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use	Device	Prototype dressing (rectangle) vs Marketed dressing (rectangle) on knees
Prototype dressing squarePrototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.	Device	Prototype dressing (square) vs Marketed dressing (square) on thighs
Marketed dressing squareCE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.	Device	Prototype dressing (square) vs Marketed dressing (square) on thighs

Primary outcome

Number of Participants With Acceptable Dressing Presence at Day 7
Time frame: 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.

6 secondary outcomes

Acceptable Dressing Presence at Day 1 and Day 3
Time frame: Day 1 and Day 3
Presence of Dressing
Time frame: Day 1, Day 3 and Day 7
Pad Integrity
Time frame: Day 1, Day 3 and Day 7
Pad Lift
Time frame: Day 1, Day 3 and Day 7
Border Lift
Time frame: Day 1, Day 3 and Day 7
Dressing Comfort
Time frame: Day 1, Day 3 and Day 7

Results and safety

Results posted to the registry on 2 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intra-Individual Comparison of Two Prototype Wound Dressings	135	135

Primary outcome: Number of Participants With Acceptable Dressing Presence at Day 7

Time frame: Day 7. Count of participants. Unit: Participants

Measure	Prototype Dressing (Rectangle) on Knee n = 135	Marketed Dressing (Rectangle) on Knee n = 135	Prototype Dressing (Square) on Thigh n = 135	Marketed Dressing (Square) on Thigh n = 135
No	48	23	35	27
Yes	87	112	100	108

Population analysed: Full analysis set (FAS) included all participants of the Safety Population with at least one post baseline assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants: Systemic Events	0 of 135 (0%)	6 of 135 (4.4%)	0 of 135
Prototype Dressing (Rectangle) on Knee	0 of 135 (0%)	11 of 135 (8.1%)	0 of 135
Marketed Dressing (Rectangle) on Knee	0 of 135 (0%)	7 of 135 (5.2%)	0 of 135
Prototype Dressing (Square) on Thigh	0 of 135 (0%)	6 of 135 (4.4%)	0 of 135
Marketed Dressing (Square) on Thigh	0 of 135 (0%)	4 of 135 (3%)	0 of 135

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kirstin Deuble-Bente principal investigator

SGS proderm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prototype dressing rectangle, Marketed dressing rectangle and Prototype dressing square in people with Healthy, run by Smith & Nephew, Inc. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acceptable Dressing Presence at Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06700850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.