Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596434
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
4-Aminopyridine to Treat Skin Burns
Sponsor:
None
Organization:
None
Study Overview
Official Title:
4-Aminopyridine to Treat Skin Burns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin There is a need to develop treatments to accelerate and improve healing of burn injuries More research is needed to evaluate the role of 4-AP a promising new agent with an excellent safety profile on wound and burn healing The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients
Detailed Description:
Burn treatment has not appreciably changed in decades Most treatments focus on infection prevention and control as well as fluid management This is because burns are universally infected with bacteria allowed to infiltrate deeper tissues by the absence of a skin barrier If bacteria can now get into these tissues the problem is only made worse by the large amount of hydration that now can get out into the environment from the open wound Desiccation sets in with deeper tissues losing fluids This renders tissue significantly more susceptible to further infection as dry tissues are less perfused and less capable of fighting infectious insults Desiccation also robs burned patients of fluids vital to sustain cardiopulmonary function Without skin patients essentially lose fluids and cannot perfuse even the most vital organs with time
Research in the field focuses on preventing complications and temporizing these two factors No regenerative treatments are currently offered to accelerate wound healing and few investigative treatments are ready for translation to human trials Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols An adjuvant regenerative burn treatment is needed
The purpose of this study is to evaluate the role of local 4-aminopyridine 4-AP on the treatment of burn wounds to accelerate healing
Research in the field focuses on preventing complications and temporizing these two factors No regenerative treatments are currently offered to accelerate wound healing and few investigative treatments are ready for translation to human trials Most of the pipelines for future treatment involve long development timelines and still focus chiefly on infection control instead of driving tissue to regenerate and heal faster A significant gap is the need for a regenerative burn treatment that can be trialed while still allowing the use of current protocols An adjuvant regenerative burn treatment is needed
The purpose of this study is to evaluate the role of local 4-aminopyridine 4-AP on the treatment of burn wounds to accelerate healing
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