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A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border).
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
The properties of a wound dressing can have a significant impact on wound healing and on the risk of developing infections. The ideal wound dressing should have good contact with the wound and be effective in absorbing and holding fluids. Biatain® Silicone uses 3DFit technology, which may support better contact with the wound, help to absorb fluid more effectively and reduce the risk of leakage. These properties may support faster wound healing and reduce complications.
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). All products used in this study are CE-marked medical devices which are already available in the UK. The main objective is to compare the reduction in wound area over four weeks between the two treatment groups. The study will also look at other aspects of wound healing and compare the costs of the dressings and the participants' quality of life during the study period. In a subgroup of participants, ultrasound will be used to assess the contact between the dressings and the wound.
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. Participants will be inpatients or outpatients recruited through 12-18 Tissue Viability Units and hospitals across the UK. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Border with Aquacel Extra Hydrofiber | Active Comparator | 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 |
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| Biatain® Silicone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatain® Silicone | Device | Wound care dressing |
| |
| Mepilex Border with Aquacel Extra Hydrofiber |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Wound Area Reduction (WAR) During Four Weeks | 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. | Baseline and four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products | 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. | Baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Voegeli | University of Winchester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk Community Health and Care NHS Trust | Norwich | Bowthorpe Road Norwich | NR2 3TU | United Kingdom | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2023 |
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The clinical investigation is a two-arms, open-labelled, stratified, randomized, controlled, multicentre investigation comparing the clinical performance of Biatain® Silicone with standard of care in chronic wounds with wound depth down to 20 mm.
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| Device |
Wound care dressing |
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| Milton Keynes University Hospital |
| Milton Keynes |
| Buckinghamshire |
| MK6 5LD |
| United Kingdom |
| North Cumbria Integrated Care | Carlisle | Cumbria | CA2 7HY | United Kingdom |
| Homerton Hospital | London | Greater London | E9 6SR | United Kingdom |
| Somerset NHS Foundation Trust | Taunton | Somerset | TA1 5DA | United Kingdom |
| Torbay and South Devon | Torquay | Torbay | TQ2 7AA | United Kingdom |
| Leeds Teaching Hospitals | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Northumbria Healthcare | Ashington | NE63 0HP | United Kingdom |
| Pioneer Wound care and Lymphoedema Centres | Eastbourne | BN23 8AS | United Kingdom |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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Participants included subjects with chronic wounds up to 2cm of depths with either venous leg ulcers or diabetic foot ulcers.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| body mass index | Mean | Standard Deviation | kg/m^2 |
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| Wound type: Venous leg ulcer; diabetic foot ulcer | Count of Participants | Participants |
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| Wound age (month) | Mean | Standard Deviation | months |
| |||||||||||||||
| Wound depth (mm) | Mean | Standard Deviation | mm |
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| Wound area (subtracted islands) (cm2) | Mean | Standard Deviation | cm2 |
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| Comorbidities | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Wound Area Reduction (WAR) During Four Weeks | 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. | The intention to treat population | Posted | Mean | 95% Confidence Interval | Percentage of wound area reduction | Baseline and four weeks |
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| Secondary | Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products | 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. | Intention to treat population | Posted | Mean | 95% Confidence Interval | mean £ | Baseline to 4 weeks |
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Adverse events were collected during the study period, i.e., 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 51 | 1 | 51 | 6 | 51 |
| EG001 | 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 | 1 | 51 | 1 | 50 | 4 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| distended abdomen | Gastrointestinal disorders | Systematic Assessment | Unlikely device related |
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| Breathlessness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | unlikely related to device |
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| pulmonary embolism and atrial fibrillation | Cardiac disorders | Systematic Assessment | Death due to suspected pulmonary embolism and atrial fibrillation. Unrelated to device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malene Hornbak Landauro, Medical writer of Clinical strategies | Coloplast, Clinical strategies | 004549112057 | dkmhla@coloplast.com |
| Jan 9, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| Venous insufficiency |
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| Peripheral arterial disease |
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| Cardiopulmonary conditions |
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| Immune deficiencies |
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| Other |
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