Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625385
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Study Evaluating the Safety and Efficacy of the 3M VAC Peel and Place Dressing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-market Prospective Multi-center Single-arm Study Evaluating the Safety and Efficacy of the 3M VAC Peel and Place Dressing Used in Conjunction With 3M VAC Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical study is to obtain post-market safety and efficacy data when the VAC Peel and Place dressing is used in conjunction with 3M VAC Therapy
Detailed Description:
This is a prospective post-market multi-center single-arm study A target of 90 enrolled Subjects with 1 enrolled study wound per Subject is planned for this study including 60 open wounds 10 for each type of open wound and 30 closed or covered wounds 10 for each type of closedcovered wound The entire duration of the study is expected to last approximately 2 years Individual Subject participation is expected to last up to 20 days including a screening period lasting up to 5 days the day of initial treatment dressing change visits as clinically appropriate but no more than 7 days from dressing application and an end-of-treatment EOTend-of-study EOS visit between Day 7 and Day 14 after the initial dressing application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None