Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Conditions
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Partial-thickness Burn

Intervention / Treatment
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* Device: Gelling fiber wound dressing with silver


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: non-comparative, one-armed, open-labelled, multi-centre study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: main arm<br>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. | Device: Gelling fiber wound dressing with silver<br>* intervention involving a wound dressing with silver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infected or risk of infection