Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border (NCT NCT03877484)
NCT ID: NCT03877484
Last Updated: 2024-12-09
Results Overview
Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.
COMPLETED
43 participants
Baseline through 28 days (±3 days).
2024-12-09
Participant Flow
Three participants were terminated prior to study treatment, following consent, and did not meet eligibility criteria.
Participant milestones
| Measure |
ALLEVYN Gentle Border
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
Baseline characteristics by cohort
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Age, Continuous
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69.6 years
STANDARD_DEVIATION 18.6 • n=39 Participants
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Sex: Female, Male
Female
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18 Participants
n=39 Participants
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Sex: Female, Male
Male
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22 Participants
n=39 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
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38 Participants
n=39 Participants
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Race/Ethnicity, Customized
Race/Ethnicity · Missing
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2 Participants
n=39 Participants
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Body Mass Index (BMI)
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28.1 kg/m^2
STANDARD_DEVIATION 6.1 • n=39 Participants
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Wound Type
Acute
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14 Participants
n=39 Participants
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Wound Type
Chronic
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26 Participants
n=39 Participants
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Wound Duration
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158.3 days
STANDARD_DEVIATION 266.4 • n=39 Participants
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Wound Area
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11.9 cm^2
STANDARD_DEVIATION 13.8 • n=39 Participants
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Exudate Levels
None
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6 Participants
n=39 Participants
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Exudate Levels
Scant
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4 Participants
n=39 Participants
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Exudate Levels
Small
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17 Participants
n=39 Participants
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Exudate Levels
Moderate
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11 Participants
n=39 Participants
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Exudate Levels
Large
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2 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: Baseline through 28 days (±3 days).Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated using the last observation carried forward (LOCF).
Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Change in Wound Area From Baseline to End of Study Visit
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2.2 square centimeters (cm^2)
Interval 0.9 to 3.9
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SECONDARY outcome
Timeframe: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Change in wound area from baseline to 7 days, 14 days and 21 days. Wound area was measured by photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=37 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 7 days (±3 days)
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0.5 square centimeters (cm^2)
Interval -0.2 to 0.8
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Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 14 days (±3 days)
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1.2 square centimeters (cm^2)
Interval 0.5 to 2.1
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Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 21 days (±3 days)
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1.7 square centimeters (cm^2)
Interval 0.6 to 3.1
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SECONDARY outcome
Timeframe: Baseline, 7 days, 14 days, 21 days, 28 daysPopulation: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Wound depth at baseline, 7, 14, 21 and 28 days were measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=34 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 14 Days
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0.1 millimeters (mm)
Interval -0.01 to 0.3
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Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 21 Days
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0.1 millimeters (mm)
Interval -0.01 to 0.6
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Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 28 Days
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0.1 millimeters (mm)
Interval -0.01 to 0.6
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Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 7 Days
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0.1 millimeters (mm)
Interval 0.01 to 0.3
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SECONDARY outcome
Timeframe: Baseline, 7 days, 14 days, 21 days, and 28 daysPopulation: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Change in exudate wound volume measured from baseline to 7 days, 14 days, 21 days and 28 days.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=34 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 7 Days (±3 Days)
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0.07 cubic centimeter (cm^3)
Interval -0.01 to 0.2
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Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 14 Days (±3 Days)
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0.08 cubic centimeter (cm^3)
Interval -0.01 to 0.2
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Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 21 Days (±3 Days)
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0.1 cubic centimeter (cm^3)
Interval 0.01 to 0.3
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Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline to 28 Days (±3 Days)
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0.1 cubic centimeter (cm^3)
Interval 0.02 to 0.3
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SECONDARY outcome
Timeframe: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Percentage change in wound area from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=37 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 7 days (±3 days)
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9.5 percent change in wound area
Interval -37.9 to 91.8
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Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 14 days (±3 days)
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21.3 percent change in wound area
Interval -118.8 to 100.0
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Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 21 days (±3 days)
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40.8 percent change in wound area
Interval -152.8 to 100.0
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Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 28 Days
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49.9 percent change in wound area
Interval -114.0 to 100.0
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SECONDARY outcome
Timeframe: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Percentage change in wound depth from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=34 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 7 days (±3 days)
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29.1 percent change in wound depth
Interval -4402.2 to 94.6
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Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 14 days (±3 days)
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34.7 percent change in wound depth
Interval -1306.0 to 100.0
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Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 21 days (±3 days)
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40 percent change in wound depth
Interval -3795.5 to 100.0
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Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 28 Days (±3 days)
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27.7 percent change in wound depth
Interval -1433.9 to 100.0
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SECONDARY outcome
Timeframe: Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Percentage change in wound volume from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=34 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 7 days (±3 days)
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38.7 percent change in wound volume
Interval -5023.5 to 97.6
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Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 14 days (±3 days)
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21.3 percent change in wound volume
Interval -118.8 to 100.0
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Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 21 days (±3 days)
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40.8 percent change in wound volume
Interval -152.8 to 100.0
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Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)
Baseline to 28 Days (±3 days)
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49.9 percent change in wound volume
Interval -114.0 to 100.0
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SECONDARY outcome
Timeframe: Dressing application to removal, up to 7 days (±3 Days)Population: Only participants enrolled in the study with any Exudate Levels present (i.e., scant, small, moderate, or large) that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. Of the 40 participants enrolled, 34 participants had exudate present.
The count of dressings applied on participants with exudate present that experienced any dressing leakage (Yes/No).
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=242 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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Exudate Management: Number of Dressings With Leakage
Any Dressing Leakage: Yes
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34 dressings
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Exudate Management: Number of Dressings With Leakage
Any Dressing Leakage: No
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208 dressings
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SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Count of participants with wound exudate amounts identified as: * None * Scant * Small * Moderate * Large
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · None
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5 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Scant
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4 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Small
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13 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Moderate
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16 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Large
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2 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · None
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7 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Scant
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2 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Small
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19 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Moderate
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11 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Large
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1 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · None
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7 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Scant
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2 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Small
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20 Participants
|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Moderate
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9 Participants
|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Large
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2 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · None
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8 Participants
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Scant
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3 Participants
|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Small
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17 Participants
|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Moderate
|
8 Participants
|
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Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Large
|
4 Participants
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SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Count of participants with wound exudate types identified as: * None * Bloody * Serosanguineous * Serous * Purulent
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · None
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7 Participants
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Bloody
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1 Participants
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Serosanguineous
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19 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Serous
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7 Participants
|
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Purulent
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6 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · None
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7 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Bloody
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1 Participants
|
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Serosanguineous
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21 Participants
|
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Serous
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7 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Purulent
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4 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · None
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8 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Bloody
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0 Participants
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Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Serosanguineous
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19 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · None
|
5 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Bloody
|
1 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Serosanguineous
|
20 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Serous
|
11 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Purulent
|
3 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Serous
|
9 Participants
|
|
Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Purulent
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Count of participants level of odour at baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days), and 28 Days (±3 Days) identified as: * None * Mild * Moderate * Strong
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
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|---|---|
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Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline · None
|
34 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline · Mild
|
5 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline · Moderate
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Baseline · Strong
|
1 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · None
|
34 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Moderate
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Strong
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · None
|
30 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Mild
|
6 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Moderate
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
14 days (±3 Days) · Strong
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · None
|
26 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Moderate
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Strong
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · None
|
26 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Mild
|
4 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Moderate
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
28 days (±3 Days) · Strong
|
0 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
7 days (±3 Days) · Mild
|
6 Participants
|
|
Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
21 days (±3 Days) · Mild
|
6 Participants
|
SECONDARY outcome
Timeframe: Upon dressing removal, up to 7 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Overall frequency of dressing changes categorized with the following reasons(Yes/No): * Reason for dressing change routine * ALLEVYN been in place 7 days * Dressing saturated * Strikethrough * Leakage * Pain * Dressing fell off * Dressing got wet during shower/bathing * Subject removed dressing * Other
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=222 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Reason for Dressing Change
Reason for dressing change routine · No
|
34 dressings
|
|
Reason for Dressing Change
Reason for dressing change routine · Yes
|
72 dressings
|
|
Reason for Dressing Change
ALLEVYN been in place 7 days · No
|
195 dressings
|
|
Reason for Dressing Change
ALLEVYN been in place 7 days · Yes
|
27 dressings
|
|
Reason for Dressing Change
Dressing saturated · No
|
195 dressings
|
|
Reason for Dressing Change
Dressing saturated · Yes
|
27 dressings
|
|
Reason for Dressing Change
Strikethrough · No
|
197 dressings
|
|
Reason for Dressing Change
Strikethrough · Yes
|
25 dressings
|
|
Reason for Dressing Change
Leakage · No
|
212 dressings
|
|
Reason for Dressing Change
Leakage · Yes
|
10 dressings
|
|
Reason for Dressing Change
Pain · No
|
221 dressings
|
|
Reason for Dressing Change
Pain · Yes
|
1 dressings
|
|
Reason for Dressing Change
Dressing fell off · No
|
215 dressings
|
|
Reason for Dressing Change
Dressing fell off · Yes
|
7 dressings
|
|
Reason for Dressing Change
Dressing got wet during shower/bathing · No
|
220 dressings
|
|
Reason for Dressing Change
Dressing got wet during shower/bathing · Yes
|
2 dressings
|
|
Reason for Dressing Change
Subject removed dressing · No
|
221 dressings
|
|
Reason for Dressing Change
Subject removed dressing · Yes
|
1 dressings
|
|
Reason for Dressing Change
Other · No
|
146 dressings
|
|
Reason for Dressing Change
Other · Yes
|
76 dressings
|
SECONDARY outcome
Timeframe: Baseline and 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
The condition of surrounding skin (i.e., peri-wound) was assessed to ensure there was no compromise to skin condition as a result of dressing wear, which could impact the wound healing progress. Number of participants condition of the peri-wound was classified as: * Normal * Erythematous * 50% to \<75% wound covered * 25% to \<50% wound covered * \<25% wound covered * Missing
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Condition of Surrounding Skin
Baseline · Normal
|
22 Participants
|
|
Condition of Surrounding Skin
Baseline · Erythematous
|
14 Participants
|
|
Condition of Surrounding Skin
Baseline · 50% to <75% wound covered
|
0 Participants
|
|
Condition of Surrounding Skin
Baseline · 25% to <50% wound covered
|
0 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · Normal
|
18 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · Erythematous
|
9 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · 50% to <75% wound covered
|
1 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · 25% to <50% wound covered
|
0 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · <25% wound covered
|
0 Participants
|
|
Condition of Surrounding Skin
28 days (±3 Days) · Missing
|
2 Participants
|
|
Condition of Surrounding Skin
Baseline · <25% wound covered
|
4 Participants
|
|
Condition of Surrounding Skin
Baseline · Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Any signs of clinical infection (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=39 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Signs of Clinical Infection
7 days (±3 Days) · Yes
|
2 Participants
|
|
Signs of Clinical Infection
7 days (±3 Days) · No
|
37 Participants
|
|
Signs of Clinical Infection
14 days (±3 Days) · Yes
|
2 Participants
|
|
Signs of Clinical Infection
14 days (±3 Days) · No
|
34 Participants
|
|
Signs of Clinical Infection
21 days (±3 Days) · Yes
|
1 Participants
|
|
Signs of Clinical Infection
21 days (±3 Days) · No
|
31 Participants
|
|
Signs of Clinical Infection
28 days (±3 Days) · Yes
|
1 Participants
|
|
Signs of Clinical Infection
28 days (±3 Days) · No
|
29 Participants
|
SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Wound healed (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 day (±3 Days) visits.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Healing of Reference Wound
7 days (±3 Days) · Yes
|
0 Participants
|
|
Healing of Reference Wound
7 days (±3 Days) · No
|
40 Participants
|
|
Healing of Reference Wound
14 days (±3 Days) · Yes
|
1 Participants
|
|
Healing of Reference Wound
14 days (±3 Days) · No
|
35 Participants
|
|
Healing of Reference Wound
21 days (±3 Days) · Yes
|
1 Participants
|
|
Healing of Reference Wound
21 days (±3 Days) · No
|
31 Participants
|
|
Healing of Reference Wound
28 days (±3 Days) · Yes
|
1 Participants
|
|
Healing of Reference Wound
28 days (±3 Days) · No
|
29 Participants
|
SECONDARY outcome
Timeframe: Following dressing application, up to 7 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Average dressing wear time in days following application
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Average Dressing Wear Time
|
4.3 days
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Immediately after dressing applicationPopulation: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain upon each dressing application at each scheduled study visit (7 days, 14 days, 21 days) or at any routine dressing change visit occurring between the scheduled visits.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=252 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Overall Level of Pain on Dressing Application
|
1.1 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: During treatment (following each dressing application prior to removal), up to 7 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain during treatment after each dressing application at each scheduled study visit (7 days \[ ±3 days\], 14 days \[ ±3 days\], 21 days \[ ±3 days\]) or at any routine dressing change visit occurring between the scheduled visits.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=245 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Overall Level of Pain During Treatment
|
1.9 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Immediately upon dressing removalPopulation: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain on dressing removal for each dressing applied at each scheduled study visit (7 days \[ ±3 days\], 14 days \[ ±3 days\], 21 days \[ ±3 days\]) or at any routine dressing change visit occurring between the scheduled visits.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=246 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Overall Level Pain on Dressing Removal
|
1.1 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Participants scored on a scale of 0 to 10 their perceived quality of life and satisfaction with quality of life. Higher scores indicate a better outcome.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Quality of Life: Baseline
|
6.2 score on a scale
Standard Deviation 2.2
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Quality of Life: 7 days (±3 Days)
|
6.3 score on a scale
Standard Deviation 2.4
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Quality of Life: 14 days (±3 Days)
|
5.9 score on a scale
Standard Deviation 2.4
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Quality of Life: 28 days (±3 Days)
|
6.6 score on a scale
Standard Deviation 2.2
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Satisfaction with Quality of Life: Baseline
|
6.2 score on a scale
Standard Deviation 2.7
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Satisfaction with Quality of Life: 7 days (±3 Days)
|
6.0 score on a scale
Standard Deviation 3.0
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Satisfaction with Quality of Life: 14 days (±3 Days)
|
6.1 score on a scale
Standard Deviation 2.6
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Satisfaction with Quality of Life: 21 days (±3 Days)
|
6.4 score on a scale
Standard Deviation 2.6
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Satisfaction with Quality of Life: 28 days (±3 Days)
|
6.2 score on a scale
Standard Deviation 2.6
|
|
Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)
Quality of Life: 21 days (±3 Days)
|
6.5 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Scores were on a scale from 0 to 100 with a higher score indicating a better outcome across three domains that included: * Wellbeing * Physical Symptoms \& Daily Living * Social Life
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=40 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Wellbeing: Baseline
|
52.6 score on a scale
Standard Deviation 22.4
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Wellbeing: 7 days (±3 Days)
|
55.5 score on a scale
Standard Deviation 23.1
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Wellbeing: 14 days (±3 Days)
|
60.8 score on a scale
Standard Deviation 23.2
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Wellbeing: 21 days (±3 Days)
|
63.8 score on a scale
Standard Deviation 21.0
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Wellbeing: 28 days (±3 Days)
|
61.4 score on a scale
Standard Deviation 39
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Physical Symptoms & Daily Living: Baseline
|
69.9 score on a scale
Standard Deviation 21.0
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Physical Symptoms & Daily Living: 7 days (±3 Days)
|
76.4 score on a scale
Standard Deviation 17.0
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Physical Symptoms & Daily Living: 14 days (±3 Days)
|
79.2 score on a scale
Standard Deviation 17.7
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Physical Symptoms & Daily Living: 21 days (±3 Days)
|
81.2 score on a scale
Standard Deviation 16.9
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Physical Symptoms & Daily Living: 28 days (±3 Days)
|
81.2 score on a scale
Standard Deviation 17.4
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Social Life: Baseline
|
72.4 score on a scale
Standard Deviation 20.8
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Social Life: 7 days (±3 Days)
|
77.1 score on a scale
Standard Deviation 17.9
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Social Life: 14 days (±3 Days)
|
82.4 score on a scale
Standard Deviation 21.1
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Social Life: 21 days (±3 Days)
|
86.8 score on a scale
Standard Deviation 13.1
|
|
Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)
Social Life: 28 days (±3 Days)
|
85.3 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
The investigator determined retention by dressing adherence to the wound at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. Dressing adherence reported as the number of participants for each response to the question "Dressing still fully adhered?" from one of the following options: * Yes * Yes, but with the aid of tape or other material * No, study dressing partially adhered * No, study dressing not adhered
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=38 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Dressing Adherence (Retention)
7 days (±3 Days) · Yes
|
20 Participants
|
|
Dressing Adherence (Retention)
7 days (±3 Days) · Yes, but with the aid of tape or other material
|
12 Participants
|
|
Dressing Adherence (Retention)
7 days (±3 Days) · No, study dressing partially adhered
|
4 Participants
|
|
Dressing Adherence (Retention)
7 days (±3 Days) · No, study dressing not adhered
|
2 Participants
|
|
Dressing Adherence (Retention)
21 days (±3 Days) · Yes
|
20 Participants
|
|
Dressing Adherence (Retention)
21 days (±3 Days) · Yes, but with the aid of tape or other material
|
8 Participants
|
|
Dressing Adherence (Retention)
21 days (±3 Days) · No, study dressing partially adhered
|
3 Participants
|
|
Dressing Adherence (Retention)
21 days (±3 Days) · No, study dressing not adhered
|
1 Participants
|
|
Dressing Adherence (Retention)
28 days (±3 Days) · Yes
|
21 Participants
|
|
Dressing Adherence (Retention)
28 days (±3 Days) · Yes, but with the aid of tape or other material
|
5 Participants
|
|
Dressing Adherence (Retention)
28 days (±3 Days) · No, study dressing partially adhered
|
1 Participants
|
|
Dressing Adherence (Retention)
28 days (±3 Days) · No, study dressing not adhered
|
2 Participants
|
|
Dressing Adherence (Retention)
14 days (±3 Days) · Yes
|
20 Participants
|
|
Dressing Adherence (Retention)
14 days (±3 Days) · Yes, but with the aid of tape or other material
|
14 Participants
|
|
Dressing Adherence (Retention)
14 days (±3 Days) · No, study dressing partially adhered
|
1 Participants
|
|
Dressing Adherence (Retention)
14 days (±3 Days) · No, study dressing not adhered
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
The investigator determined any "bunching up" (i.e., bunching/overlap) of the dressing on the wound at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 day visits (±3 Days). Bunching of the dressing reported as the number of participants for each response to "Whether there is any bunching/overlap of dressing" from one of the following options: * None * Very Little * Moderate * Excessive
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=36 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Bunching Up of Dressing
7 days (±3 Days) · None
|
29 Participants
|
|
Bunching Up of Dressing
7 days (±3 Days) · Very Little
|
5 Participants
|
|
Bunching Up of Dressing
7 days (±3 Days) · Moderate
|
2 Participants
|
|
Bunching Up of Dressing
7 days (±3 Days) · Excessive
|
0 Participants
|
|
Bunching Up of Dressing
14 days (±3 Days) · None
|
33 Participants
|
|
Bunching Up of Dressing
14 days (±3 Days) · Very Little
|
2 Participants
|
|
Bunching Up of Dressing
14 days (±3 Days) · Moderate
|
0 Participants
|
|
Bunching Up of Dressing
28 days (±3 Days) · Moderate
|
1 Participants
|
|
Bunching Up of Dressing
28 days (±3 Days) · Excessive
|
0 Participants
|
|
Bunching Up of Dressing
14 days (±3 Days) · Excessive
|
1 Participants
|
|
Bunching Up of Dressing
21 days (±3 Days) · None
|
21 Participants
|
|
Bunching Up of Dressing
21 days (±3 Days) · Very Little
|
5 Participants
|
|
Bunching Up of Dressing
21 days (±3 Days) · Moderate
|
1 Participants
|
|
Bunching Up of Dressing
21 days (±3 Days) · Excessive
|
2 Participants
|
|
Bunching Up of Dressing
28 days (±3 Days) · None
|
25 Participants
|
|
Bunching Up of Dressing
28 days (±3 Days) · Very Little
|
1 Participants
|
SECONDARY outcome
Timeframe: Dressing application to removal, up to 7 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Overall percentage of dressing lift for each dressing application was determined from investigator responses following dressing removal at scheduled or routine dressing change visits to the question "Is the study dressing still fully adhered?" The following imputations were used when : * If the Investigator answered "Yes" then percentage lift was 0% * If the Investigator answered "Study dressing not adhered" then the percentage lift was 100% * If "Partially adhered" was selected, then the percentage lift was the percentage indicated in data
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=250 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Overall Percent of Dressing Lift
|
5.8 percentage of dressing lift
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Dressing comfort at 7 days (±3 Days) , 14 days (±3 Days), 21 days (±3 Days) and 28 day (±3 Days) visits determined by the number of participants with responses to "Dressing comfortable to wear since last visit" from one of the following options: * Very comfortable * Comfortable * Neither comfortable nor uncomfortable * Uncomfortable * Very uncomfortable
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=38 Participants
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Dressing Comfort During Wear
7 days (±3 Days) · Very comfortable
|
20 Participants
|
|
Dressing Comfort During Wear
7 days (±3 Days) · Comfortable
|
15 Participants
|
|
Dressing Comfort During Wear
7 days (±3 Days) · Neither comfortable nor uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
7 days (±3 Days) · Uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
7 days (±3 Days) · Very uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
14 days (±3 Days) · Very comfortable
|
19 Participants
|
|
Dressing Comfort During Wear
14 days (±3 Days) · Comfortable
|
15 Participants
|
|
Dressing Comfort During Wear
14 days (±3 Days) · Neither comfortable nor uncomfortable
|
0 Participants
|
|
Dressing Comfort During Wear
14 days (±3 Days) · Uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
14 days (±3 Days) · Very uncomfortable
|
0 Participants
|
|
Dressing Comfort During Wear
21 days (±3 Days) · Very comfortable
|
16 Participants
|
|
Dressing Comfort During Wear
21 days (±3 Days) · Comfortable
|
13 Participants
|
|
Dressing Comfort During Wear
21 days (±3 Days) · Neither comfortable nor uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
21 days (±3 Days) · Uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
21 days (±3 Days) · Very uncomfortable
|
0 Participants
|
|
Dressing Comfort During Wear
28 days (±3 Days) · Very comfortable
|
17 Participants
|
|
Dressing Comfort During Wear
28 days (±3 Days) · Comfortable
|
12 Participants
|
|
Dressing Comfort During Wear
28 days (±3 Days) · Neither comfortable nor uncomfortable
|
1 Participants
|
|
Dressing Comfort During Wear
28 days (±3 Days) · Uncomfortable
|
0 Participants
|
|
Dressing Comfort During Wear
28 days (±3 Days) · Very uncomfortable
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Leakage was determined based on the response to "How have you found your experience in terms of leakage?" where 0 indicated unacceptable level of leakage and 10 indicated no leakage.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=244 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Leakage
|
8.6 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Moisture was determined based on the response to "How have you found your experience in terms of the feeling of moisture on your skin underneath the dressing" where 0 indicated unacceptable feeling of moisture and 10 indicated no feeling of moisture on the skin.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=244 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Moisture
|
8.5 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Odour was determined based on the response to "How have you found your experience in terms of odour?" where 0 indicated unacceptable level of odour and 10 indicated no odour.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=244 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Odour
|
8.8 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Exudate was determined based on the response to "How have you found your experience in terms of visible exudate?" where 0 indicated unacceptable level of visible exudate and 10 indicated no visible exudate.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=243 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Exudate
|
6.5 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Protection was determined based on the response to "How protected did the dressing make your wound feel?" where 0 indicated unacceptable level of protection and 10 indicated very protected.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=244 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Protection
|
8.7 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of dressing comfort?" where 0 indicated unacceptable level of comfort and 10 indicated very comfortable.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=39 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Comfort
|
8.9 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline through end of treatment, up to 28 days (±3 days)Population: All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated.
Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of being able to maintain a normal showering routine? (NA if patient does not have a normal showering routine)" where 0 indicated unacceptable level of impact (unable to bathe) and 10 indicated no negative impact.
Outcome measures
| Measure |
ALLEVYN Gentle Border
n=214 dressings
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Patient Assessment Scale: Showering
|
7.8 score on a scale
Standard Deviation 3.0
|
Adverse Events
ALLEVYN Gentle Border
Serious adverse events
| Measure |
ALLEVYN Gentle Border
n=40 participants at risk
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Injury, poisoning and procedural complications
Wound complication
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
Other adverse events
| Measure |
ALLEVYN Gentle Border
n=40 participants at risk
ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
|
|---|---|
|
Infections and infestations
Wound infection
|
7.5%
3/40 • Number of events 3 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Infections and infestations
Infection
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
General disorders
Medical device site erosion
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60