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

A Randomised Controlled Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone With Standard of Care Dressing Including Filler in Chronic Wounds

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer
• Intervention / Treatment: Device: Mepilex Border with Aquacel Extra Hydrofiber; Device: Biatain® Silicone

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ashington, United Kingdom, NE63 0HP
    • Northumbria Healthcare
  • Eastbourne, United Kingdom, BN23 8AS
    • Pioneer Wound care and Lymphoedema Centres
  • Bowthorpe Road Norwich
    • Norwich, Bowthorpe Road Norwich, United Kingdom, NR2 3TU
      • Norfolk Community Health and Care NHS Trust
  • Buckinghamshire
    • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
      • Milton Keynes University Hospital
  • Cumbria
    • Carlisle, Cumbria, United Kingdom, CA2 7HY
      • North Cumbria Integrated Care
  • Greater London
    • London, Greater London, United Kingdom, E9 6SR
      • Homerton Hospital
  • Somerset
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Somerset NHS Foundation Trust
  • Torbay
    • Torquay, Torbay, United Kingdom, TQ2 7AA
      • Torbay and South Devon
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Mepilex Border with Aquacel Extra Hydrofiber; Wound care dressing
Experimental: 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.	Device: Biatain® Silicone; Wound care dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Chair: David Voegeli, University of Winchester

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Varicose Veins; Diabetic Neuropathies; Foot Diseases; Ulcer; Varicose Ulcer; Leg Ulcer; Diabetic Foot; Foot Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CP351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No