Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care

Not Applicable

Completed

Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer

Interventions: Device: Mepilex Border with Aquacel Extra Hydrofiber
Device: Biatain® Silicone

Registration Number: NCT05786612

Lead Sponsor: Coloplast A/S

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

Has given written consent to participate by signing the Informed Consent Signature Form
Is at least 18 years of age and has full legal capacity
Has a venous leg ulcer (VLU) (C6 of the CEAP classification(1)) or a non-infected diabetic foot ulcer (DFU) with a duration longer than 8 weeks but no longer than 24 months
Has a wound with depth1 down to 20 mm
Has a maximum wound depth1 relative to wound diameter
Has a wound with exudate levels requiring a filler and a standard secondary dressing
Has acceptance of compression therapy in case of a VLU or off-loading in case of a DFU, according to local standards
For subjects with diabetes, has HbA1c ≤ 10% or ≤ 86 mmol/mol, measured within the last 3 months prior to inclusion

Exclusion Criteria

Wound is infected. For DFUs, has infection severity mild-severe according to the IWGDF/IDSA guideline For VLUs, has 2 or more clinical signs of infection as defined in protocol, based on clinical judgement by investigator/tissue viability nurse
Wounds is with exposed tendons, is with bones or has fistulas
Wound is with cavity, or is undermined or tunnelling
Subject is receiving chemotherapy
Subject has ankle-brachial pressure index (ABPI) below 0.8 measured within one month prior to inclusion
Wound is larger than 10 x10 cm
Currently enrolled in another wound care de-vice investigation unless co-enrolment has been agreed with the sponsor

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex Border with Aquacel Extra Hydrofiber	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
Biatain® Silicone	Biatain® Silicone	The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management.

Primary Outcome Measures

Name	Time	Method
Percentage Wound Area Reduction (WAR) During Four Weeks	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products	Baseline to 4 weeks	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.

Trial Locations

Locations (9): Norfolk Community Health and Care NHS Trust
🇬🇧
Norwich, Bowthorpe Road Norwich, United Kingdom
Milton Keynes University Hospital
🇬🇧
Milton Keynes, Buckinghamshire, United Kingdom
North Cumbria Integrated Care
🇬🇧
Carlisle, Cumbria, United Kingdom
Homerton Hospital
🇬🇧
London, Greater London, United Kingdom
Somerset NHS Foundation Trust
🇬🇧
Taunton, Somerset, United Kingdom
Torbay and South Devon
🇬🇧
Torquay, Torbay, United Kingdom
Leeds Teaching Hospitals
🇬🇧
Leeds, West Yorkshire, United Kingdom
Northumbria Healthcare
🇬🇧
Ashington, United Kingdom
Pioneer Wound care and Lymphoedema Centres
🇬🇧
Eastbourne, United Kingdom