Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Coloplast A/S52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Partial-thickness Burn

Interventions

Gelling fiber wound dressing with silverDEVICE

intervention involving a wound dressing with silver

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (5)

North Bristol Southmead Hospital

Westbury, Bristol, United Kingdom

Buckinghamshire Healthcare NHS Trust

Aylesbury, Buckinghamshire, United Kingdom

Queen Alexandra Hospital, Portsmouth Hospital University Trust

Cosham, United Kingdom

Queen Victoria Hospital NHS foundation trust

East Grinstead, United Kingdom

Outcomes

Primary Outcomes

Percentage of Wounds Healed Within 14 Days

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.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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