Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134843
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-11-04
Brief Title:
Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
Sponsor:
Hobart W Harris
Organization:
Vitruvian Medical Devices Inc
Study Overview
Official Title:
A Single-Blind Randomized Controlled Single Center Clinical Study to Assess the Safety and Efficacy of DERMASEAL Advanced Wound Care Dressing for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 to determine whether the combination biologicdrug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery
Detailed Description:
This is a single center single-blind randomized controlled phase 12 study of patients undergoing treatment of a cutaneous wound involving a split-thickness skin graft A subjects study duration will be for up to a total of 16 weeks from randomization to end of study This includes 1 week of treatment followed by 3 weeks of Standard of Care plus a final follow-up visit 12 weeks after complete wound closure or the end of Standard of Care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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