Healthy
Conditions
Keywords
Foam dressing, healthy volunteers, intact skin, wear-time
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. Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee. 2. 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. 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.
Interventions
DEVICEPrototype dressing rectangle
Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use.
DEVICEMarketed dressing rectangle
CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use
DEVICEPrototype dressing square
Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
DEVICEMarketed dressing square
CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acceptable Dressing Presence at Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable Dressing Presence at Day 1 and Day 3 | 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. |
| Presence of Dressing | Day 1, Day 3 and Day 7 | 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). |
| Pad Integrity | Day 1, Day 3 and Day 7 | 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 |
| Pad Lift | Day 1, Day 3 and Day 7 | 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 |
| Border Lift | Day 1, Day 3 and Day 7 | 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 |
| Dressing Comfort | Day 1, Day 3 and Day 7 | 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 |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKirstin Deuble-Bente
SGS proderm
Participant flow
Recruitment details
The enrollment period started on 28 October 2024 and ended on 09 January 2025. It required approximately 10 weeks to recruit all participants.
Pre-assignment details
Prior to application of the four different dressings (two prototype and two marketed dressings), a physical skin assessment occurred to ensure skin was healthy, intact & hair free. Upon eligibility confirmation, the investigator would apply the appropriate dressing to the randomized right/left knee (rectangle dressing) and right/left thigh (square dressing). All participants would receive all dressings (i.e., each participant is their own control with the comparator dressing).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.19 years STANDARD_DEVIATION 11.29 |
| Height | 167.33 centimeters (cm) STANDARD_DEVIATION 8.31 |
| Region of Enrollment Germany | 135 participants |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 14 Participants |
| Weight | 77.48 kilograms (kg) STANDARD_DEVIATION 16.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 135 | 0 / 135 | 0 / 135 | 0 / 135 |
| other Total, other adverse events | 6 / 135 | 11 / 135 | 7 / 135 | 6 / 135 | 4 / 135 |
| serious Total, serious adverse events | 0 / 135 | 0 / 135 | 0 / 135 | 0 / 135 | 0 / 135 |
Outcome results
None listed