N/A
Completed N=102
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
Source: ClinicalTrials.gov NCT05786612 ↗Enrolled (actual)
102
Serious AEs
2.0%
Results posted
Mar 2025
Primary outcomePrimary: Percentage Wound Area Reduction (WAR) During Four Weeks — 43; 54.3 Percentage of wound area reduction
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Wound Area Reduction (WAR) During Four Weeks |
43; 54.3 | — |
| SECONDARY Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products |
21.4; 14.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT05786612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.