Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 52
- Locations
- 9
- Primary Endpoint
- Percentage of Wounds Healed Within 14 Days
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
main arm
Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a two weeks period with planned dressing changes once pr. week.
Intervention: Gelling fiber wound dressing with silver (Device)
Outcomes
Primary Outcomes
Percentage of Wounds Healed Within 14 Days
Time Frame: 2 weeks
The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater.
Secondary Outcomes
No secondary outcomes reported