Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

December 1, 2023 updated by: Coloplast A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cosham, United Kingdom, P06 3LY
        • Not yet recruiting
        • Queen Alexandra Hospital, Portsmouth Hospital University Trust
        • Contact:
          • Christiane Vorwerk
      • East Grinstead, United Kingdom
        • Recruiting
        • Queen Victoria Hospital Nhs Foundation Trust
        • Contact:
          • Baljit Dheansa
      • Newcastle, United Kingdom, NE3 3HD
        • Recruiting
        • Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
    • Bristol
      • Westbury, Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • North Bristol Southmead Hospital
        • Contact:
          • Christopher Wearn
    • Buckinghamshire
      • Aylesbury,, Buckinghamshire, United Kingdom, HP21 8AL
        • Not yet recruiting
        • Buckinghamshire Healthcare NHS Trust
        • Contact:
          • Fadi Issa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: Gelling fiber wound dressing with silver
intervention involving a wound dressing with silver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of wounds healed within 14 days
Time Frame: week 2
to evaluate clinical performance in terms of percentage of wounds achieving healing within 14 days (+/- 2 days). Complete healing is defined as ≥ 95% reepithelisation.
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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