Isaac Zilinsky1, Tami Brutman Barazani2, Denis Visentin3, Kiran Ahuja3, Uriel Martinowitz2, Josef Haik4,5. 1. Mohs Unit, Sheba Medical Center, Tel Hashomer, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 2. The National Hemophilia Center and Thrombosis Institute, Sheba Medical Center, Tel Hashomer, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 3. School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia. 4. Burns Unit, The Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Tel Hashomer, Affiliated to Sackler School of Medicine, Tel Aviv University, Israel. 5. Burn Injury Research Node, Institute for Health Research, University of Notre Dame Fremantle, Fremantle, Western Australia, Australia.
Abstract
BACKGROUND: Topical application, oral, and IV injection of tranexamic acid (TXA) have been used to reduce surgical bleeding. OBJECTIVE: To evaluate the safety and efficacy of TXA injected subcutaneously to reduce bleeding during dermatologic surgery. METHODS: In this double-blinded, placebo-controlled, randomized prospective study, 131 patients were randomized to subcutaneous injection of lidocaine 2% diluted 1:1 with either saline (placebo) or TXA 100 mg/1 mL before surgery. Before the second stage or closure, size measurements of bloodstain impregnation on Telfa and surgical wound size were recorded and analyzed using mixed-effects linear regression. Subjective evaluation of hemostasis was performed using 4-point scale grading and analyzed using Fischer's exact test. RESULTS:One hundred twenty-seven patients completed the study. The bloodstain to surgical wound size ratio was smaller in the TXA group (1.77) compared with the placebo group (2.49) (p < .001). An improved effect of TXA on bleeding was observed in the subgroup of patients receiving anticoagulants (mean difference; 95% confidence interval; -0.83; -1.20 to -0.46 p < .001). The subjective hemostasis assessment was significantly better in the TXA group overall (p = .043) and anticoagulant subgroup (p = .001) compared with the placebo group. CONCLUSION: Subcutaneous injection of TXA was safe, reduced bleeding during dermatologic surgery, and particularly effective for patients receiving anticoagulation treatment.
RCT Entities:
BACKGROUND: Topical application, oral, and IV injection of tranexamic acid (TXA) have been used to reduce surgical bleeding. OBJECTIVE: To evaluate the safety and efficacy of TXA injected subcutaneously to reduce bleeding during dermatologic surgery. METHODS: In this double-blinded, placebo-controlled, randomized prospective study, 131 patients were randomized to subcutaneous injection of lidocaine 2% diluted 1:1 with either saline (placebo) or TXA 100 mg/1 mL before surgery. Before the second stage or closure, size measurements of bloodstain impregnation on Telfa and surgical wound size were recorded and analyzed using mixed-effects linear regression. Subjective evaluation of hemostasis was performed using 4-point scale grading and analyzed using Fischer's exact test. RESULTS: One hundred twenty-seven patients completed the study. The bloodstain to surgical wound size ratio was smaller in the TXA group (1.77) compared with the placebo group (2.49) (p < .001). An improved effect of TXA on bleeding was observed in the subgroup of patients receiving anticoagulants (mean difference; 95% confidence interval; -0.83; -1.20 to -0.46 p < .001). The subjective hemostasis assessment was significantly better in the TXA group overall (p = .043) and anticoagulant subgroup (p = .001) compared with the placebo group. CONCLUSION: Subcutaneous injection of TXA was safe, reduced bleeding during dermatologic surgery, and particularly effective for patients receiving anticoagulation treatment.
Authors: Rafael Campos-Cuerva; Beatriz Fernández-Muñoz; Francisco Farfán López; Sheila Pereira Arenas; Mónica Santos-González; Luis Lopez-Navas; Miguel Alaminos; Antonio Campos; Jordi Muntané; Carmen Cepeda-Franco; Miguel Ángel Gómez-Bravo Journal: J Tissue Eng Regen Med Date: 2019-03-20 Impact factor: 3.963