Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

NCT05824026 | Completed Results

• 1 other identifier: CP357
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Partial-thickness Burn

Keywords

infected or risk of infection

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (1)

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.

Device: Gelling fiber wound dressing with silver

Interventions

Gelling fiber wound dressing with silver DEVICE

intervention involving a wound dressing with silver

main arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (5)

North Bristol Southmead Hospital

Westbury, Bristol, BS10 5NB, United Kingdom

Location

Buckinghamshire Healthcare NHS Trust

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

Location

Queen Alexandra Hospital, Portsmouth Hospital University Trust

Cosham, P06 3LY, United Kingdom

Location

Queen Victoria Hospital NHS foundation trust

East Grinstead, United Kingdom

Location

Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE3 3HD, United Kingdom

Location

Results Point of Contact

• Title: Clinical Strategy Project Manager: Johanne Louise Gotfredsen
• Organization: Coloplast A/S

dkjoat@coloplast.com

004549113350

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 21, 2023
• Study Start: October 27, 2023
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)