Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629506
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
MicroMatrix Flex in Tunneling Wounds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation of MicroMatrix Flex in Wounds Complicated by Tunneling and Undermining
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:
To evaluate the safety and performance of MicroMatrix Flex in subjects with wounds complicated by tunneling andor undermining features
Detailed Description:
The purpose of this study is to evaluate the safety and performance of MicroMatrix Flex in subjects with wounds complicated by tunneling andor undermining features Prospective data will be collected to assess the rate of wound areavolume reduction progression toward closure and post-operative complications at 12 weeks and rate of skin graft take when applicable up to 16 weeks follow-up
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