Biatain Silicone 3DFIT Study (BISIL Study)
Research type
Research Study
Full 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
IRAS ID
315855
Contact name
David Voegeli
Contact email
Sponsor organisation
Coloplast Danmark A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The properties of a wound dressing can have an 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® EXTRA 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 chronic wounds no deeper than 2cm. Participants will be inpatients or outpatients recruited through >12 Tissue Viability Units and hospitals across the UK. The study is a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for the duration of the study. 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 from January 2023 to January 2024.
The study is funded by Coloplast A/S (Denmark).REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0820
Date of REC Opinion
6 Dec 2022
REC opinion
Further Information Favourable Opinion