Investigation of the Clinical Performance of Biatain Fiber Ag on Burns

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05824026
• Collaborator: (none)
• Enrollment: 50
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 9
• Patients Per Site: 10
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial-thickness Burn	Device: Gelling fiber wound dressing with silver	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: non-comparative, one-armed, open-labelled, multi-centre study.non-comparative, one-armed, open-labelled, multi-centre study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. percentage of wounds healed within 14 days [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Has signed informed consent

2. Is 18 years or above

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 20% (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. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Bristol Southmead Hospital	Westbury	Bristol	United Kingdom	BS10 5NB
2	Buckinghamshire Healthcare NHS Trust	Aylesbury,	Buckinghamshire	United Kingdom	HP21 8AL
3	Queen Alexandra Hospital, Portsmouth Hospital University Trust	Cosham		United Kingdom	P06 3LY
4	Queen Victoria Hospital NHS foundation trust	East Grinstead		United Kingdom
5	Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle		United Kingdom	NE3 3HD

Sponsors and Collaborators

• Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT05824026
• Other Study ID Numbers: CP357
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 21, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Coloplast A/S: infected or risk of infection
• Additional relevant MeSH terms: Burns

Study Results

No Results Posted as of Apr 21, 2023