Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
Key facts
- Who runs it
- Coloplast A/S
- Where
- United Kingdom9 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 102 people enrolled
- Started
- 30 Jan 2023
- Ended
- 27 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Biatain® Silicone
- Mepilex Border with Aquacel Extra Hydrofiber
- Record updated
- 5 March 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Subject is receiving chemotherapy
- Subject has ankle-brachial pressure index (ABPI) below 0.8 measured within one month prior to inclusion
- 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
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
Read full original descriptionShow less
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.
The 2 groups in the trial
- Mepilex Border with Aquacel Extra HydrofiberExisting treatment, for comparison
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® SiliconeTreatment being tested
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 5 March 2025