Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

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.

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).