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

Primary Purpose

Venous Leg Ulcer, Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Biatain® Silicone
Mepilex Border with Aquacel Extra Hydrofiber
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norfolk Community Health and Care NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mepilex Border with Aquacel Extra Hydrofiber

Biatain® Silicone

Arm Description

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

The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management.

Outcomes

Primary Outcome Measures

Percentage wound area reduction during the investigational test period of four weeks

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2023
Last Updated
March 24, 2023
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05786612
Brief Title
A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With SoC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 chron-ic wounds with wound depth down to 20 mm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mepilex Border with Aquacel Extra Hydrofiber
Arm Type
Active Comparator
Arm Description
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
Arm Title
Biatain® Silicone
Arm Type
Experimental
Arm Description
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management.
Intervention Type
Device
Intervention Name(s)
Biatain® Silicone
Intervention Description
Wound care dressing
Intervention Type
Device
Intervention Name(s)
Mepilex Border with Aquacel Extra Hydrofiber
Intervention Description
Wound care dressing
Primary Outcome Measure Information:
Title
Percentage wound area reduction during the investigational test period of four weeks
Time Frame
Test period of four weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
Test period of four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katja Bergenholtz
Phone
+4549112159
Email
DKKABE@coloplast.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Louise Mohr
Phone
+4549113506
Email
DKMLOM@coloplast.com
Facility Information:
Facility Name
Norfolk Community Health and Care NHS Trust
City
Norwich
State/Province
Bowthorpe Road Norwich
ZIP/Postal Code
NR2 3TU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Towers
Phone
01603 272251/07392 879779
Email
Laura.Towers@nchc.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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