Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
- Conditions
- Partial-thickness Burn
- Interventions
- Device: Gelling fiber wound dressing with silver
- Registration Number
- NCT05824026
- Lead Sponsor
- Coloplast A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description main arm Gelling fiber wound dressing with silver 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.
- Primary Outcome Measures
Name Time Method percentage of wounds healed within 14 days week 2 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
Name Time Method
Trial Locations
- Locations (5)
North Bristol Southmead Hospital
🇬🇧Westbury, Bristol, United Kingdom
Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Buckinghamshire Healthcare NHS Trust
🇬🇧Aylesbury,, Buckinghamshire, United Kingdom
Queen Alexandra Hospital, Portsmouth Hospital University Trust
🇬🇧Cosham, United Kingdom
Queen Victoria Hospital NHS foundation trust
🇬🇧East Grinstead, United Kingdom