Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503406
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
A Prospective Study Using SupraSDRM in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study Using SupraSDRM in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
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:
This is a prospective randomized controlled multi-center clinical study comparing SupraSDRM to standard of care wound dressing BTM in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed
Detailed Description:
Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial An area 5 and 125 cm2 deemed not immediately ready to accept skin graft will be designated as the study site The study site will be randomized to receive either SupraSDRM or the SoC wound dressing NovoSorb BTM
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