HealthyNCT06831448
Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin.
A study testing Prototype dressing, Marketed dressing 1 and Marketed dressing 2 in people with Healthy, run by Smith & Nephew, Inc. at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prototype dressing, Marketed dressing 1 and Marketed dressing 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2025to 17 Mar 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 18 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 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]
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 (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read more
The study will compare:
- Prototype dressing vs Marketed dressing 1 on thighs and shins.
- 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.
Read the 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:
- Prototype dressing vs Marketed dressing 1 on thighs and shins
- 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
- Being tested
- Prototype dressing, Marketed dressing 1, Marketed dressing 2
- 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 dressingDevice
Five-layer foam dressing. Size: 10cm x 10 cm. Topical application. Single use.
Marketed dressing 1Device
Five-layer foam dressing. Size: 12.9cm × 12.9cm. Topical application. Single use.
Marketed dressing 2Device
Five-layer foam dressing. Size: 10cm x 10 cm. Topical application. Single use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Prototype dressing; Device: Marketed dressing 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable Dressing Presence at Day 7
Count of dressings with acceptable dressing presence was 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.
Measured: Day 7
Secondary outcomes (6)
Acceptable Dressing Presence at Day 1 and Day 3
Count of dressings with acceptable dressing presence determined by 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 dressings 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 dressings categorized as one of the following percentage categories:
- 0% (no change)
- 1-25%
- 26%-50%
- 51%-75%
- 76-100%
- Dressing missing
Measured: Day 1, Day 3 and Day 7
Pad Lift
Lift of the dressing pad assessed at Day 1, 3 and 7 to determine the extent of pad area lifted and no longer adhered to the participant's skin by one of the following pad lift percentage categories:
- 0% (no lift)
- 1-25%
- 26%-50%
- 51%-75%
- 76-100%
- Dressing missing
Measured: Day 1, Day 3 and Day 7
Border Lift
Lift of the dressing border assessed at Day 1, 3 and 7 to determine the extent of the border area lifted and no longer adhered to the participant's skin by one of the following border lift percentage categories:
- 0% (no lift)
- 1-25%
- 26%-50%
- 51%-75%
- 76-100%
- Dressing missing
Measured: Day 1, Day 3 and Day 7
Dressing Comfort
Dressing comfort assessed at Day 1, 3 and 7 by the participant's answer to the question "was the dressing comfortable during wear?" from one of the following responses:
- Yes
- No
- 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.
- First posted18 Feb 2025
- Study start27 Jan 2025
- Primary completion17 Mar 2025
- Study completion17 Mar 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.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, Principal investigator, SGS proderm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831448
- Sponsor's protocol ID
- HVS2313
- Other IDs
- CIV-24-02-046076
- Status last verified
- Jan 2025
- First submitted
- 12 Feb 2025
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 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 a Prototype Multilayer Foam Dressing in Comparison to ALLEVYN◊ LIFE and Another Established Medical Device.
- ClinicalTrials.gov ID
- NCT06831448
- Acronym / sponsor ID
- HVS2313
- Conditions
- Healthy
- Keywords
- Foam dressing, healthy volunteers, intact skin, wear-time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Posted 9 Jun 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 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:
- Prototype dressing vs Marketed dressing 1 on thighs and shins.
- 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:
- Prototype dressing vs Marketed dressing 1 on thighs and shins
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prototype dressing vs Marketed dressing 1 | Other | Device: Prototype dressing, Device: Marketed dressing 1The 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. |
| Prototype dressing vs Marketed dressing 2 | Other | Device: Prototype dressing, Device: Marketed dressing 2The 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
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 dressingFive-layer foam dressing. Size: 10cm x 10 cm. Topical application. Single use. | Device | Prototype dressing vs Marketed dressing 1, Prototype dressing vs Marketed dressing 2 |
| Marketed dressing 1Five-layer foam dressing. Size: 12.9cm × 12.9cm. Topical application. Single use. | Device | Prototype dressing vs Marketed dressing 1 |
| Marketed dressing 2Five-layer foam dressing. Size: 10cm x 10 cm. Topical application. Single use. | Device | Prototype dressing vs Marketed dressing 2 |
Primary outcome
Acceptable Dressing Presence at Day 7
Time frame: Day 7
Count of dressings with acceptable dressing presence was 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.
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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, Marketed dressing 1 and Marketed dressing 2 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 8 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 9 Jun 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 9 Jun 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?
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?
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 9 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.