Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-04-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Partial-thickness Burn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

non-comparative, one-armed, open-labelled, multi-centre study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Gelling fiber wound dressing with silver

Intervention Type DEVICE

intervention involving a wound dressing with silver

Interventions

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Gelling fiber wound dressing with silver

intervention involving a wound dressing with silver

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No