N/A
Completed N=52
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Partial-thickness Burn
Source: ClinicalTrials.gov NCT05824026 ↗
Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Sep 2025
Primary outcomePrimary: Percentage of Wounds Healed Within 14 Days — 83.7; 74.8; 70.6 percentage of wounds healed
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Wounds Healed Within 14 Days |
83.7; 74.8; 70.6 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05824026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.