Partial-thickness BurnNCT05824026
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
A study testing Gelling fiber wound dressing with silver in people with Partial-thickness Burn, run by Coloplast A/S at 5 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial-thickness Burn
- What is being tested?
- Gelling fiber wound dressing with silver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 27 Oct 2023to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Buckinghamshire Healthcare NHS Trust
Aylesbury, Buckinghamshire, HP21 8AL
Queen Alexandra Hospital, Portsmouth Hospital University Trust
Cosham, P06 3LY
Queen Victoria Hospital NHS foundation trust
East Grinstead
Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE3 3HD
North Bristol Southmead Hospital
Westbury, Bristol, BS10 5NB
About this study
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.
Read the 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.
- Conditions
- Partial-thickness Burn
- Being tested
- Gelling fiber wound dressing with silver
- Keywords
- infected or risk of infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelling fiber wound dressing with silverDevice
intervention involving a wound dressing with silver
| Study group | Role | What they receive |
|---|---|---|
| main arm | Other | 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. Receives: Device: Gelling fiber wound dressing with silver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start27 Oct 2023
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial-thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-comparative, one-armed, open-labelled, multi-centre study.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824026
- Sponsor's protocol ID
- CP357
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2023
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
- ClinicalTrials.gov ID
- NCT05824026
- Acronym / sponsor ID
- CP357
- Conditions
- Partial-thickness Burn
- Keywords
- infected or risk of infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-comparative, one-armed, open-labelled, multi-centre study.
| Arm | Type | Receives |
|---|---|---|
| main arm | Other | Device: Gelling fiber wound dressing with silverNon comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a two weeks period with planned dressing changes once pr. week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelling fiber wound dressing with silverintervention involving a wound dressing with silver | Device | main arm |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelling fiber wound dressing with silver in people with Partial-thickness Burn, run by Coloplast A/S at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Wounds Healed Within 14 Days (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.