Trial Outcomes & Findings for A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing (NCT NCT01897285)
NCT ID: NCT01897285
Last Updated: 2016-06-17
Results Overview
* 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)
COMPLETED
NA
20 participants
7 days
2016-06-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
Baseline characteristics by cohort
| Measure |
All Participants: AQUACEL® Foam Adhesive Dressings
n=20 Participants
Original adhesive + test adhesive
AQUACEL® foam adhesive dressings
|
|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.46 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
* 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)
Outcome measures
| Measure |
AQUACEL® Foam Adhesive Dressing - Original Adhesive
n=20 Participants
Original adhesive
AQUACEL® foam adhesive dressing
|
AQUACEL® Foam Adhesive Dressing - Test Adhesive
n=20 Participants
Test adhesive
AQUACEL® foam adhesive dressing
|
|---|---|---|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Adhesion Excellent
|
6 participants
|
5 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Adhesion Good
|
1 participants
|
0 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Adhesion Average
|
1 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Adhesion Poor
|
0 participants
|
0 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Adhesion Very Poor
|
12 participants
|
14 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Dressing conformability Missing
|
12 participants
|
14 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Dressing conformability Excellent
|
6 participants
|
5 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Dressing conformability Good
|
2 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Ease of removal Missing
|
12 participants
|
14 participants
|
|
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
|
6 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Comfort during removal Missing
|
12 participants
|
14 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Comfort during removal Excellent
|
6 participants
|
6 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Comfort during removal Good
|
2 participants
|
0 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Dressing integrity missing
|
12 participants
|
14 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Arm Dressing integrity Excellent
|
8 participants
|
6 participants
|
|
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
|
14 participants
|
|
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
|
6 participants
|
|
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
|
0 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Adhesion Excellent
|
0 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Adhesion Good
|
2 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Adhesion Average
|
2 participants
|
0 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Dressing Conformability Excellent
|
0 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Dressing Conformability Good
|
2 participants
|
1 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Dressing Conformability Average
|
2 participants
|
0 participants
|
|
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
|
2 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Comfort During Removal Excellent
|
4 participants
|
2 participants
|
|
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
Back Dressing Integrity Excellent
|
4 participants
|
2 participants
|
|
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
|
2 participants
|
SECONDARY outcome
Timeframe: 7 daysSafety 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.
Outcome measures
| Measure |
AQUACEL® Foam Adhesive Dressing - Original Adhesive
n=20 Participants
Original adhesive
AQUACEL® foam adhesive dressing
|
AQUACEL® Foam Adhesive Dressing - Test Adhesive
n=20 Participants
Test adhesive
AQUACEL® foam adhesive dressing
|
|---|---|---|
|
Safety - the Nature and Frequency of Adverse Events
|
8 participants
|
5 participants
|
Adverse Events
AQUACEL® Foam Adhesive Dressing - Original Adhesive
AQUACEL® Foam Adhesive Dressing - Test Adhesive
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AQUACEL® Foam Adhesive Dressing - Original Adhesive
n=20 participants at risk
Original adhesive
AQUACEL® foam adhesive dressing
|
AQUACEL® Foam Adhesive Dressing - Test Adhesive
n=20 participants at risk
Test adhesive
AQUACEL® foam adhesive dressing
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Arm: General disorders and administration site conditions
|
30.0%
6/20 • 7 days
|
25.0%
5/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Arm: Application site pruritus
|
30.0%
6/20 • 7 days
|
25.0%
5/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Arm: Skin and subcutaneous tissue disorders
|
25.0%
5/20 • 7 days
|
10.0%
2/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
4/20 • 7 days
|
5.0%
1/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Arm: Skin exfoliation
|
5.0%
1/20 • 7 days
|
5.0%
1/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Arm: Skin irritation
|
5.0%
1/20 • 7 days
|
0.00%
0/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Back:General disorders and administration site conditions
|
10.0%
2/20 • 7 days
|
15.0%
3/20 • 7 days
|
|
Skin and subcutaneous tissue disorders
Back: Application site pruritus
|
10.0%
2/20 • 7 days
|
15.0%
3/20 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality Agreement
- Publication restrictions are in place
Restriction type: OTHER