Safety and Performance of Dressing Adhesive on Healthy Volunteers
Conditions
Keywords
Performance and safety of the AQUACEL® foam adhesive dressing
Brief summary
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.
Interventions
DEVICEAQUACEL® foam adhesive dressing
Sponsors
ConvaTec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent * Be a healthy volunteer and be over 18 years of age * Be willing to attend two scheduled visits for application and removal of the device and adverse event review * Have healthy unbroken skin
Exclusion criteria
* Subjects with a history of sensitivity to any one of the components of the device being studied * Female subjects who are currently pregnant or lactating * Subjects who are not willing and able to attend the 'clinic' for the required assessments * Subjects with excessive hair on their backs * Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | 7 days | * Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult * Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable * Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - the Nature and Frequency of Adverse Events | 7 days | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants: AQUACEL® Foam Adhesive Dressings Original adhesive + test adhesive
AQUACEL® foam adhesive dressings | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Participants: AQUACEL® Foam Adhesive Dressings |
|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 10.46 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
* Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult * Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable * Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)
Time frame: 7 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing integrity Excellent | 8 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Very Poor | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal missing | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Ease of removal Missing | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal None | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Good | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal Minimal | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Ease of removal very easy | 8 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Excellent | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Missing | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Good | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Missing | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Average | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Poor | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Excellent | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Excellent | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Good | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Excellent | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Average | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Good | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Ease of Removal Very Easy | 4 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Average | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Comfort During Removal Excellent | 4 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing integrity missing | 12 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Integrity Excellent | 4 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Good | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesive Residue on Removal None | 4 participants |
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Excellent | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesive Residue on Removal None | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Excellent | 5 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Good | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Average | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Poor | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesion Very Poor | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Missing | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Excellent | 5 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing conformability Good | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Ease of removal Missing | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Ease of removal very easy | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Missing | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Excellent | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Comfort during removal Good | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing integrity missing | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Dressing integrity Excellent | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal missing | 14 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal None | 6 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Arm Adhesive residue on removal Minimal | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Excellent | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Good | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Adhesion Average | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Excellent | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Good | 1 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Conformability Average | 0 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Ease of Removal Very Easy | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Comfort During Removal Excellent | 2 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Back Dressing Integrity Excellent | 2 participants |
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.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AQUACEL® Foam Adhesive Dressing - Original Adhesive | Safety - the Nature and Frequency of Adverse Events | 8 participants |
| AQUACEL® Foam Adhesive Dressing - Test Adhesive | Safety - the Nature and Frequency of Adverse Events | 5 participants |