Use of Tranexamic Acid in Reduction of Post-Op Complications in Mohs Micrographic Surgery

Skin Neoplasms Clinical Trial

Official title: Local Injection of Tranexamic Acid May Reduce Bleeding, Injection Pain, and Other Post-op Complications During Mohs Micrographic Surgery

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is to evaluate the use of locally injected tranexamic acid (TXA) under the skin during Mohs micrographic surgery for removal of skin cancers in patients on anticoagulation. TXA may be helpful in reducing bleeding and pain during surgery, and may also lead to fewer post-operative complications following surgery such as graft loss, specifically in patients on blood-thinners.

Clinical Trial Description

The primary objective of this study is to evaluate the efficacy of subcutaneous infiltration of tranexamic acid (TXA) in the reduction of peri- and post-operative complications including bleeding, infections, flap and graft loss in anticoagulated patients undergoing Mohs micrographic surgery. A secondary objective is to evaluate the ability of TXA to increase the pH of lidocaine with epinephrine, and whether it causes less pain than the alternative during injection of local anesthetic.

TXA may serve as an effective local antifibrinolytic agent to decrease perioperative and postoperative bleeding while also causing less injection pain in patients undergoing Mohs surgery.

Background:

TXA is a well-established antifibrinolytic agent used in many surgical fields to effectively reduce post-operative bleeding. TXA is a synthetic lysine analogue that prevents the lysis of polymerized fibrin in blood clots. It has been used intravenously, orally, and subcutaneously to reduce bleeding during orthopedic procedures, to manage postpartum bleeding, and in trauma patients to control significant hemorrhage. It has also been used intravenously to reduce the need for blood transfusions in cardiac and liver transplantation.The safety of TXA has been verified in numerous publications across multiple medical specialties. Additionally, the pH of TXA ranges from 6-8, indicating that it may serve as an effective buffering agent and cause less pain with injection of anesthetic agents.

Many institutions have begun to use tranexamic acid to reduce postoperative bleeding. The medication is now readily available in the Pyxis of the investigators. The use of TXA within the wound bed and underlying undermined edges of flaps performed in patients who are anticoagulated is becoming the standard of care. Anecdotally, this has been quite successful in reducing post operative bruising and post operative bleeding requiring an emergency visit. In this protocol, the study arm involving the use of TXA and the study arm without the use of TXA are currently standard of care and are currently routinely used intraoperatively in clinical practice.

The investigators are performing this study to examine the efficacy of TXA as a safe, local antifibrinolytic agent in dermatologic surgeries and will analyze postoperative bleeding as well as other postoperative complications. ;

Related Conditions & MeSH terms

• Postoperative Complications
• Skin Neoplasms

• NCT number: NCT04630886
• Study type: Interventional
• Source: University of Massachusetts, Worcester
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: June 16, 2021
• Completion date: December 2023