Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

Last updated: August 21, 2025
Sponsor: Coloplast A/S
Overall Status: Completed

Phase

N/A

Condition

Hyponatremia

Skin Wounds

Treatment

Gelling fiber wound dressing with silver

Clinical Study ID

NCT05824026
CP357
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 TotalBody 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 (assessedby 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 theinvestigator).

Exclusion

Exclusion Criteria:

  1. Is pregnant/breastfeeding

  2. Is currently receiving or has within the past 60 days received radio- and/orchemotherapy (low doses radio- and/or chemotherapy is allowed for other indicationsthan 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).

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Gelling fiber wound dressing with silver
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
April 26, 2024

Study 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.

Connect with a study center

  • North Bristol Southmead Hospital

    Westbury, Bristol BS10 5NB
    United Kingdom

    Site Not Available

  • North Bristol Southmead Hospital

    Westbury 2634483, Bristol BS10 5NB
    United Kingdom

    Site Not Available

  • Buckinghamshire Healthcare NHS Trust

    Aylesbury 2656719, Buckinghamshire HP21 8AL
    United Kingdom

    Site Not Available

  • Buckinghamshire Healthcare NHS Trust

    Aylesbury,, Buckinghamshire HP21 8AL
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital, Portsmouth Hospital University Trust

    Cosham, P06 3LY
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital, Portsmouth Hospital University Trust

    Cosham 2652294, P06 3LY
    United Kingdom

    Site Not Available

  • Queen Victoria Hospital NHS foundation trust

    East Grinstead,
    United Kingdom

    Site Not Available

  • Queen Victoria Hospital NHS foundation trust

    East Grinstead 2650435,
    United Kingdom

    Site Not Available

  • Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE3 3HD
    United Kingdom

    Site Not Available

  • Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle 6695976, NE3 3HD
    United Kingdom

    Site Not Available

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