Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345833
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Brief Title:
Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Tranexamic acid TXA is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen this prevents the conversion of plasminogen to plasmin TXA will be applied to a randomly assigned side of the face during facelift surgery The intervention groups will include 1 TXA mixed with standard local consisting 14 lidocaine with 1100000 epinephrine 3 TXA on TXA-soaked pledgets applied for 10 minutes and 1 TXA with local plus 3 TXA-soaked pledgets Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face
Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage cite The main concern with intravenous TXA is the increased risk for the potential formation of blood clots mainly in patients with clotting disorders such as Facor V Leiden and patients on estrogen containing medication A recent systemic review with metanalysis by Wang etal contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events12 Given the low rate of adverse events while using TXA systemically this protocols application of TXA topically andor locally negates the risk for any potential systemic adverse effects No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date
Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage cite The main concern with intravenous TXA is the increased risk for the potential formation of blood clots mainly in patients with clotting disorders such as Facor V Leiden and patients on estrogen containing medication A recent systemic review with metanalysis by Wang etal contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events12 Given the low rate of adverse events while using TXA systemically this protocols application of TXA topically andor locally negates the risk for any potential systemic adverse effects No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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