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

NCT05786612 | Completed Results

• 1 other identifier: CP351
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Venous Leg Ulcer; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products

  Baseline to 4 weeks

Study Arms (2)

Mepilex Border with Aquacel Extra Hydrofiber

ACTIVE COMPARATOR

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

Biatain® Silicone

EXPERIMENTAL

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

Interventions

Biatain® Silicone DEVICE

Wound care dressing

Biatain® Silicone

Mepilex Border with Aquacel Extra Hydrofiber DEVICE

Wound care dressing

Mepilex Border with Aquacel Extra Hydrofiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (9)

Norfolk Community Health and Care NHS Trust

Norwich, Bowthorpe Road Norwich, NR2 3TU, United Kingdom

Location

Milton Keynes University Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

Location

North Cumbria Integrated Care

Carlisle, Cumbria, CA2 7HY, United Kingdom

Location

Homerton Hospital

London, Greater London, E9 6SR, United Kingdom

Location

Somerset NHS Foundation Trust

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Torbay and South Devon

Torquay, Torbay, TQ2 7AA, United Kingdom

Location

Leeds Teaching Hospitals

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Northumbria Healthcare

Ashington, NE63 0HP, United Kingdom

Location

Pioneer Wound care and Lymphoedema Centres

Eastbourne, BN23 8AS, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Malene Hornbak Landauro, Medical writer of Clinical strategies
• Organization: Coloplast, Clinical strategies

dkmhla@coloplast.com

004549112057

Study Officials

• David Voegeli

  University of Winchester

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The clinical investigation is a two-arms, open-labelled, stratified, randomized, controlled, multicentre investigation comparing the clinical performance of Biatain® Silicone with standard of care in chronic wounds with wound depth down to 20 mm.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: March 27, 2023
• Study Start: January 30, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)