An Early Phase 1 interventional study of Tranexamic acid injection and Lidocaine Epinephrine in Skin Neoplasms, sponsored by Riley McLean. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Riley McLean · Early Phase 1, Interventional, and Supportive care
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.
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 34 is below the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →This is the only study on the registry with Riley McLean as lead sponsor.
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Exclusion Criteria:
The TXA group will receive 2% lidocaine with 1:100,000 epinephrine mixed 50/50 with 50mg/ml TXA (with 50% dilution, this will yield 1% lidocaine with 1:200,000 epi).
Drug: Tranexamic acid injection · Drug: Lidocaine Epinephrine
The control group will use the routine local anesthetic of buffered 1% lidocaine with 1:200,000 epinephrine.
Drug: Lidocaine Epinephrine
subcutaneous injection of 50mg/ml TXA
subcutaneous injection of 1% lidocaine mixed with 1:200,000 epinephrine
Postoperative Complications
Primary outcome measures will be the number of postoperative complications, including infection, bleeding (necessitating phone calls to providers or additional clinic visits), hematoma formation, and flap or graft failure.
Time frame: From day of surgery to 12 weeks post-operation
Hemostasis
The quality of intraoperative hemostasis will be measured on a 1-4 scale titled "Quality of the Field", with 1 being "excellent, better than expected/predicted for this procedure" and 4 being "poor, oozing that required adding gauze dressing and local pressure" (the higher the score, the worse the outcome)
Time frame: during surgery
Injection Pain
Injection pain will be measured via self reported pain intensity within the first 30 minutes of initial injection on the day of surgery. The pain scale is scored 0-10 (0 = no pain; 10 = unable to move). The higher the score, the worse the outcome.
Time frame: 30 minutes post initial injection
Plan to share: No
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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