Clinical trial NCT05786612: Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
Official title: A Randomised Controlled Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone With Standard of Care Dressing Including Filler in Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Diabetic Foot Ulcer
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Wound Area Reduction (WAR) During Four Weeks
timeFrame: Baseline and four weeks
Secondary outcomes:
measure: Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
state: Bowthorpe Road Norwich
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
state: Buckinghamshire
city: Carlisle
country: United Kingdom
facility: North Cumbria Integrated Care
state: Cumbria
city: London
country: United Kingdom
facility: Homerton Hospital
state: Greater London
city: Taunton
country: United Kingdom
facility: Somerset NHS Foundation Trust
state: Somerset
city: Torquay
country: United Kingdom
facility: Torbay and South Devon
state: Torbay
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
state: West Yorkshire
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare
city: Eastbourne
country: United Kingdom
facility: Pioneer Wound care and Lymphoedema Centres
Study officials:
affiliation: University of Winchester
name: David Voegeli
role: STUDY_CHAIR
References: