Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824026
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2023-04-11
Brief Title:
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
Investigation of the Clinical Performance of Biatain Fiber Ag on Burns
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 V0V1 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
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 V0V1 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None