Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Launched by COLOPLAST A/S · Apr 11, 2023

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has signed informed consent
• • 2. Is between 18 -65 years (both included)
• • 3. Is capable of following study procedure (assessed by investigator).
• • 4. Has a partial thickness burn wound
• • 5. Has a burn wound that is infected or at risk of infection (assessed by investigator)
• • 6. 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).
• • 7. The wound should fit under a 20x30 cm dressing (600 cm2) or smaller
• • 8. The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
• • 9. Has a wound that has medium to high level of exudate (assessed by the investigator)
• • 10. Is suitable to use the test product for wound treatment (assessed by the investigator).
• Exclusion Criteria:
• • 1. Is pregnant/breastfeeding
• • 2. 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)
• • 3. Known history of skin sensitivity to any components of the test dressings
• • 4. \>72 hours from time of injury
• • 5. Intake of antibiotics within one week before the start of the enrolment
• • 6. Use of chemical debridement
• • 7. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).