Back to resultsInvestigation of the Clinical Performance of Biatain Fiber Ag on Burns
Primary Purpose
Partial-thickness Burn
Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gelling fiber wound dressing with silver
Sponsored by
About this trial
This is an interventional treatment trial for Partial-thickness Burn focused on measuring infected or risk of infection
Eligibility Criteria
Inclusion Criteria: Has signed informed consent Is between 18 -65 years (both included) Is capable of following study procedure (assessed by investigator). Has a partial thickness burn wound Has a burn wound that is infected or at risk of infection (assessed by investigator) The size of burn (including both study wound and non-study injuries) has a Total Body Surface Area (TBSA) less than 10% (assessed by investigator). The wound should fit under a 20x30 cm dressing (600 cm2) or smaller The shape and location of the wound should be suitable for photo capture (assessed by the investigator). Has a wound that has medium to high level of exudate (assessed by the investigator) Is suitable to use the test product for wound treatment (assessed by the investigator). Exclusion Criteria: Is pregnant/breastfeeding Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area) Known history of skin sensitivity to any components of the test dressings >72 hours from time of injury Intake of antibiotics within one week before the start of the enrolment Use of chemical debridement Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Sites / Locations
- North Bristol Southmead Hospital
- Buckinghamshire Healthcare NHS Trust
- Queen Alexandra Hospital, Portsmouth Hospital University Trust
- Queen Victoria Hospital NHS foundation trust
- Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
main arm
Arm Description
Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a two weeks period with planned dressing changes once pr. week.
Outcomes
Primary Outcome Measures
percentage of wounds healed within 14 days
to evaluate clinical performance in terms of percentage of wounds achieving healing within 14 days (+/- 2 days). Complete healing is defined as ≥ 95% reepithelisation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05824026
Brief Title
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Official Title
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 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
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a partial thickness burn wound, which is infected or at risk of infection.
Participants will be asked to wear the test dressing in a two weeks period(+/- 2 days) consisting of 3-4 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
Detailed Description
The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study.
The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds. The product has a classification III, as it contains the active ingredient silver.
The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU.
The total study duration for the subject will be approximately two weeks (+/- 2 days), consisting of a two-week test period and 4 study visits (V0/V1, V2 and V3). V3 will also terminate the 2-week study period.
The primary endpoint is percentage of wounds healed within 14 days (≥ 95 % reepithelialisation) The clinical investigation will be conducted in a total of 50 eligible subjects with a partial thickness burn wound that are infected or at risk of infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial-thickness Burn
Keywords
infected or risk of infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-comparative, one-armed, open-labelled, multi-centre study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
main arm
Arm Type
Other
Arm Description
Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a two weeks period with planned dressing changes once pr. week.
Intervention Type
Device
Intervention Name(s)
Gelling fiber wound dressing with silver
Intervention Description
intervention involving a wound dressing with silver
Primary Outcome Measure Information:
Title
percentage of wounds healed within 14 days
Description
to evaluate clinical performance in terms of percentage of wounds achieving healing within 14 days (+/- 2 days). Complete healing is defined as ≥ 95% reepithelisation.
Time Frame
week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has signed informed consent
Is between 18 -65 years (both included)
Is capable of following study procedure (assessed by investigator).
Has a partial thickness burn wound
Has a burn wound that is infected or at risk of infection (assessed by investigator)
The size of burn (including both study wound and non-study injuries) has a Total Body Surface Area (TBSA) less than 10% (assessed by investigator).
The wound should fit under a 20x30 cm dressing (600 cm2) or smaller
The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
Has a wound that has medium to high level of exudate (assessed by the investigator)
Is suitable to use the test product for wound treatment (assessed by the investigator).
Exclusion Criteria:
Is pregnant/breastfeeding
Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
Known history of skin sensitivity to any components of the test dressings
>72 hours from time of injury
Intake of antibiotics within one week before the start of the enrolment
Use of chemical debridement
Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Krogh
Phone
+4549113245
Email
dkmekr@coloplast.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Krarup Simonsen
Phone
+4549111873
Email
dktksi@coloplast.com
Facility Information:
Facility Name
North Bristol Southmead Hospital
City
Westbury
State/Province
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Buckinghamshire Healthcare NHS Trust
City
Aylesbury,
State/Province
Buckinghamshire
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Queen Alexandra Hospital, Portsmouth Hospital University Trust
City
Cosham
ZIP/Postal Code
P06 3LY
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Vorwerk
Facility Name
Queen Victoria Hospital NHS foundation trust
City
East Grinstead
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baljit Dheansa
Facility Name
Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE3 3HD
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Lewis
Phone
+44 0191 282 9674
Email
christopher.lewis10@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
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