A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With SoC

Diabetic Foot Ulcer Clinical Trial

— BISIL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786612
• Other study ID #: CP351
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: January 2024
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Biatain® Silicone
Wound care dressing
• Mepilex Border with Aquacel Extra Hydrofiber
Wound care dressing

Locations

Country	Name	City	State
United Kingdom	Norfolk Community Health and Care NHS Trust	Norwich	Bowthorpe Road Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage wound area reduction during the investigational test period of four weeks		Test period of four weeks
Secondary	Total treatment costs during the investigational test period based on the number of dressings used during the investigation and the unit price of the products		Test period of four weeks