Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-03-046336 | Other Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype dressing rectangle | Device | Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and Day 3 |
| Presence of Dressing |
Not provided
Inclusion Criteria:
Footnote:
* at least 10% of participants are aged >55 years
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente | SGS proderm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm | Schenefeld | Schleswig-Holstein | 22869 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
The enrollment period started on 28 October 2024 and ended on 09 January 2025. It required approximately 10 weeks to recruit all participants.
| ID | Title | Description |
|---|---|---|
| FG000 | Intra-Individual Comparison of Two Prototype Wound Dressings | All participants received all four different dressings (two prototype dressings and two marketed dressings). The dressings were grouped by shape and applied to their designated application site via randomization to create two comparison pairs. Pair 1 consisted of the rectangle prototype dressing and rectangle marketed dressing applied to the randomized right/left knee on the participant. Pair 2 consisted of the square prototype dressing and square marketed dressing applied to the randomized right/left thigh on the same participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population (SP) included all participants in the investigation that received at least one of the test products, regardless of the number of further assessments.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intra-Individual Comparison of Two Prototype Wound Dressings | All participants received all four different dressings (two prototype dressings and two marketed dressings). The dressings were grouped by shape and applied to their designated application site via randomization to create two comparison pairs. Pair 1 consisted of the rectangle prototype dressing and rectangle marketed dressing applied to the randomized right/left knee on the participant. Pair 2 consisted of the square prototype dressing and square marketed dressing applied to the randomized right/left thigh on the same participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) included all participants of the Safety Population with at least one post baseline assessment. | Posted | Count of Participants | Participants | Day 7 |
|
Adverse events were collected upon dressing application on day 0 to dressing removal at day 7.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants: Systemic Events | All participants for events with no product relationship (i.e., unrelated to prototype or marketed dressings) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | 07811407089 | datasharing.gcs@smith-nephew.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 26, 2024 | Oct 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2025 | Oct 3, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Marketed dressing rectangle | Device | CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use |
|
| Prototype dressing square | Device | Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. |
|
| Marketed dressing square | Device | CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. |
|
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). |
| 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:
| 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:
| 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:
| 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:
| Day 1, Day 3 and Day 7 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| OG001 | Marketed Dressing (Rectangle) on Knee | Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location. Marketed dressing (rectangle): CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use |
| OG002 | Prototype Dressing (Square) on Thigh | Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location. Prototype dressing (square): Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. |
| OG003 | Marketed Dressing (Square) on Thigh | Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location. Marketed dressing (square): CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. |
|
|
| Secondary | 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. | Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1 and Day 3 |
|
|
|
| Secondary | 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). | Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1, Day 3 and Day 7 |
|
|
|
| Secondary | 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:
| Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1, Day 3 and Day 7 |
|
|
|
| Secondary | 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:
| Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1, Day 3 and Day 7 |
|
|
|
| Secondary | 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:
| Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1, Day 3 and Day 7 |
|
|
|
| Secondary | 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:
| Per Protocol Population (PP) included all participants of the Full Analysis Set that finished the investigation in accordance with the clinical investigational plan (i.e., protocol) without major protocol deviations. There were 8 participants with major protocol deviations that were excluded from analysis. The data reported is separated by each dressing specified as intended because all participants received all dressings (i.e., same participant population was analyzed for each dressing). | Posted | Count of Participants | Participants | Day 1, Day 3 and Day 7 |
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 6 |
| 135 |
| EG001 | Prototype Dressing (Rectangle) on Knee | Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The Prototype dressing (rectangle) was applied to the randomized knee location. Prototype dressing (rectangle): Prototype multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use. | 0 | 135 | 0 | 135 | 11 | 135 |
| EG002 | Marketed Dressing (Rectangle) on Knee | Each participant received a comparison pair for Prototype dressing (rectangle) vs Marketed dressing (rectangle) applied to knees (one dressing per knee). Each dressing of the comparison pair was randomized to either the right or left knee in a 1:1 ratio. The marketed dressing (rectangle) was applied to the randomized knee location. Marketed dressing (rectangle): CE marked multilayer foam wound dressing. Size: 30x10cm. Topical application. Single use | 0 | 135 | 0 | 135 | 7 | 135 |
| EG003 | Prototype Dressing (Square) on Thigh | Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The prototype dressing (square) was applied to the randomized thigh location. Prototype dressing (square): Prototype multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. | 0 | 135 | 0 | 135 | 6 | 135 |
| EG004 | Marketed Dressing (Square) on Thigh | Each participant received a comparison pair for Prototype dressing (square) vs Marketed dressing (square) applied to thighs (one dressing per thigh). Each dressing of the comparison pair was randomized to either the right or left thigh in a 1:1 ratio. The marketed dressing (square) was applied to the randomized thigh location. Marketed dressing (square): CE marked multilayer foam wound dressing. Size: 7.5x7.5cm. Topical application. Single use. | 0 | 135 | 0 | 135 | 4 | 135 |
| Pain | General disorders | Systematic Assessment |
|
| Skin Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Inflammation/ Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Gastrointestinal Tract Infection | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Period Cramps | Reproductive system and breast disorders | Systematic Assessment |
|
| Fracture to little finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
The Investigator is employed by CRO: SGS proderm GmbH. The Study Protocol, section 21.3 states: Investigators may publish results generated from this clinical investigation, but not without prior agreement with, and review by, the sponsor, as detailed in the clinical study agreement between sponsor and CRO/investigator.
| Yes |
|
| Day 3: Acceptable dressing presence |
|
| Yes |
|
| Day 3: Is the dressing in place? |
|
| Day 7: Is the dressing in place? |
|
| 1-25% |
|
| 26%-50% |
|
| 51%-75% |
|
| 76-100% |
|
| Dressing missing |
|
| Day 3: Pad integrity |
|
| Day 7: Pad integrity |
|
| 1-25% |
|
| 26%-50% |
|
| 51%-75% |
|
| 76-100% |
|
| Dressing missing |
|
| Day 3: Pad lift |
|
| Day 7: Pad lift |
|
| 1-25% |
|
| 26%-50% |
|
| 51%-75% |
|
| 76-100% |
|
| Dressing missing |
|
| Day 3: Border lift |
|
| Day 7: Border lift |
|
| Yes |
|
| Dressing missing |
|
| Day 3: Was the dressing comfortable during wear? |
|
| Day 7: Was the dressing comfortable during wear? |
|