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AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study participants: AQUACEL® foam adhesive dressings | Experimental | Original adhesive + test adhesive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUACEL® foam adhesive dressing | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) |
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - the Nature and Frequency of Adverse Events | Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded. Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwen Lawrence, RGN | Wirral University Teaching Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Development Centre, Deeside Industrial Park | Deeside | Flintshire | CH5 2NU | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Original adhesive and Test adhesive on right and left upper arm and right and left lower back. AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Ten male (50%) and ten female (50%) healthy volunteers were enrolled into the study with a mean age of 37.1 years.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants: AQUACEL® Foam Adhesive Dressings | Original adhesive + test adhesive AQUACEL® foam adhesive dressings |
| 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 | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) |
| 20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as 'other' for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments. | Posted | Number | participants | 7 days |
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AQUACEL® Foam Adhesive Dressing - Original Adhesive | Original adhesive AQUACEL® foam adhesive dressing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm: General disorders and administration site conditions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
Many dressings detached from the skin when the volunteers were at home/away from the clinic and prior to returning for the assessments. It was therefore not possible for the Investigator to give a rating for several parameters on several volunteers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Gwenneth Lawrence | Arrowe Park Hospital | 0151 678 5111 | 8362 | gwen.lawrence@nhs.net |
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| 7 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | AQUACEL® Foam Adhesive Dressing - Original Adhesive | Original adhesive AQUACEL® foam adhesive dressing |
| OG001 | AQUACEL® Foam Adhesive Dressing - Test Adhesive | Test adhesive AQUACEL® foam adhesive dressing |
|
|
| Secondary | Safety - the Nature and Frequency of Adverse Events | Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded. Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction. | Posted | Number | participants | 7 days |
|
|
|
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | AQUACEL® Foam Adhesive Dressing - Test Adhesive | Test adhesive AQUACEL® foam adhesive dressing | 0 | 20 | 5 | 20 |
| Arm: Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arm: Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arm: Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arm: Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back:General disorders and administration site conditions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back: Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Confidentiality Agreement