Investigation of the Clinical Performance of Biatain Fiber Ag on Burns (NCT05824026) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
United Kingdom52 participantsStarted 2023-10-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).
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