Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers

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 venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 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 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 four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period. The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.

Official Title
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Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcer

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Biatain Fiber Ag applied to participants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signed informed consent Is 18 years or above Is capable of following study procedure (assessed by the investigator). Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks The shape of the wound should be possible to fit under a 10x10 cm dressing The shape and location of the wound should be suitable for photo capture (assessed by the investigator). Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator). Has a wound that has medium to high level of exudate (assessed by the investigator). Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3 Agrees to wear compression therapy daily in combination with the test dressing Is suitable to use the test product for wound treatment (assessed by the investigator). Exclusion Criteria: Is pregnant/breastfeeding Wound is older than 12 months Wound with exposed tendons or bones or has fistulas Wound which is undermined or tunneling 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 treatment dressings Intake of antibiotics within one week before the start of the enrolment 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

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 four weeks period with planned dressing changes once pr. week. | Device: Biatain Fiber Ag applied to participants<br>* Intervention involving a wound gelling fiber dressing with silver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean relative wound area reduction as indication of total wound healing | Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed. | period of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing