Trial Outcomes & Findings for Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care (NCT NCT05786612)
NCT ID: NCT05786612
Last Updated: 2025-03-05
Results Overview
Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Baseline and four weeks
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
one screening failure
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
n=51 Participants
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
n=51 Participants
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 12 • n=51 Participants
|
69.7 years
STANDARD_DEVIATION 12 • n=51 Participants
|
71.6 years
STANDARD_DEVIATION 12.1 • n=102 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=51 Participants
|
21 Participants
n=51 Participants
|
44 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=51 Participants
|
30 Participants
n=51 Participants
|
58 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
body mass index
|
30.4 kg/m^2
STANDARD_DEVIATION 9.6 • n=51 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 7.8 • n=51 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 8.7 • n=102 Participants
|
|
Wound type: Venous leg ulcer; diabetic foot ulcer
Venous leg ulcer
|
40 Participants
n=51 Participants
|
39 Participants
n=51 Participants
|
79 Participants
n=102 Participants
|
|
Wound type: Venous leg ulcer; diabetic foot ulcer
Diabetic foot ulcer
|
11 Participants
n=51 Participants
|
12 Participants
n=51 Participants
|
23 Participants
n=102 Participants
|
|
Wound age (month)
|
5.7 months
STANDARD_DEVIATION 4.8 • n=51 Participants
|
5.1 months
STANDARD_DEVIATION 4.4 • n=51 Participants
|
5.4 months
STANDARD_DEVIATION 4.6 • n=102 Participants
|
|
Wound depth (mm)
|
2.7 mm
STANDARD_DEVIATION 2.3 • n=51 Participants
|
2.3 mm
STANDARD_DEVIATION 2 • n=51 Participants
|
2.5 mm
STANDARD_DEVIATION 2.2 • n=102 Participants
|
|
Wound area (subtracted islands) (cm2)
|
5.6 cm2
STANDARD_DEVIATION 6.1 • n=51 Participants
|
6.1 cm2
STANDARD_DEVIATION 8.8 • n=51 Participants
|
5.8 cm2
STANDARD_DEVIATION 7.5 • n=102 Participants
|
|
Comorbidities
Diabetes
|
16 Participants
n=51 Participants
|
16 Participants
n=51 Participants
|
32 Participants
n=102 Participants
|
|
Comorbidities
Venous insufficiency
|
43 Participants
n=51 Participants
|
41 Participants
n=51 Participants
|
84 Participants
n=102 Participants
|
|
Comorbidities
Peripheral arterial disease
|
8 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
13 Participants
n=102 Participants
|
|
Comorbidities
Cardiopulmonary conditions
|
13 Participants
n=51 Participants
|
19 Participants
n=51 Participants
|
32 Participants
n=102 Participants
|
|
Comorbidities
Immune deficiencies
|
3 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
|
Comorbidities
Other
|
14 Participants
n=51 Participants
|
12 Participants
n=51 Participants
|
26 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Baseline and four weeksPopulation: The intention to treat population
Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size.
Outcome measures
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
n=50 Participants
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
n=47 Participants
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Percentage Wound Area Reduction (WAR) During Four Weeks
|
43 Percentage of wound area reduction
Interval 26.5 to 59.6
|
54.3 Percentage of wound area reduction
Interval 37.1 to 71.5
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Intention to treat population
Total cost, £, was calculated as the number of products used multiplied by the unit price of the product. The price was extracted from the Drug Tariff on the date of Last Patient Out.
Outcome measures
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
n=50 Participants
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
n=47 Participants
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products
|
21.4 mean £
Interval 16.9 to 26.0
|
14.3 mean £
Interval 9.6 to 19.0
|
Adverse Events
Mepilex Border With Aquacel Extra Hydrofiber
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Biatain® Silicone
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
n=51 participants at risk
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
n=50 participants at risk
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Gastrointestinal disorders
distended abdomen
|
2.0%
1/51 • Number of events 1 • Adverse events were collected during the study period, i.e., 4 weeks.
|
0.00%
0/50 • Adverse events were collected during the study period, i.e., 4 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness
|
2.0%
1/51 • Number of events 1 • Adverse events were collected during the study period, i.e., 4 weeks.
|
0.00%
0/50 • Adverse events were collected during the study period, i.e., 4 weeks.
|
|
Cardiac disorders
pulmonary embolism and atrial fibrillation
|
0.00%
0/51 • Adverse events were collected during the study period, i.e., 4 weeks.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected during the study period, i.e., 4 weeks.
|
Other adverse events
| Measure |
Mepilex Border With Aquacel Extra Hydrofiber
n=51 participants at risk
Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing
|
Biatain® Silicone
n=50 participants at risk
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin rash
|
11.8%
6/51 • Number of events 6 • Adverse events were collected during the study period, i.e., 4 weeks.
|
8.0%
4/50 • Number of events 5 • Adverse events were collected during the study period, i.e., 4 weeks.
|
Additional Information
Malene Hornbak Landauro, Medical writer of Clinical strategies
Coloplast, Clinical strategies
Phone: 004549112057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place