Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind, Randomized Controlled Trial

Abstract

Breast cancer affects one in every eight women, many of whom will undergo treatment with mastectomy and implant-based breast reconstruction. 1 Breast cancer reconstruction has been shown to improve patientreported outcomes in physical, psychosocial, and sexual well-being domains. 2 Even with advances in prosthetic devices, reconstructive techniques, and mastectomy flap quality, recent reviews have demonstrated that surgical complications can arise in up to 20% of alloplastic breast Background: Excess fluid accumulation (seroma/hematoma) around the breast implant after reconstruction can lead to significant complications. Topical administration of tranexamic acid (TXA) may reduce fluid accumulation and reduce postoperative complications. This trial aims to investigate whether TXA-treated mastectomy pockets will exhibit less postoperative fluid production and complications. Methods: This paired, double-blind, randomized, controlled trial enrolled patients undergoing bilateral mastectomies with immediate direct-to-implant reconstruction. In each patient, one breast was randomized to receive 3 g of TXA (100 cc), and the other received 100 cc of normal saline. The blinded solutions were soaked in the mastectomy pocket for 5 minutes before implant placement. Postoperatively, daily drain outputs, complications, and baseline demographics were recorded. Results: Fifty-three eligible patients, representing 106 breasts, were enrolled. All patients underwent bilateral nipple-sparing mastectomies. After randomization, TXA was placed in the right breast in 30 patients (56.6%). The use of topical TXA resulted in a mean drain output reduction of 30.5% (range, −83.6% to 26.6%). Drains on the TXA-treated breast were eligible for removal 1.4 days (range, 0 to 4 days) sooner than the control side. The TXA-treated group had three complications (5.67%) versus 15 (28.3%) in the control group (OR, 0.1920; P = 0.0129). Specifically, for operative hematomas, the TXA group had none (0%), versus three in the control group (5.7%) (OR, 0.1348; P = 0.18). Conclusions: Soaking the mastectomy bed with 3% topical TXA before implant insertion leads to a decrease in drain output and a decrease in complications. Topical administration of TXA represents an option to decrease complications in alloplastic breast reconstruction.

Management of complications following implant-based breast reconstruction: a narrative review

“…Intraoperative elimination of dead space can also aid in seroma prevention and may be achieved in various ways, including excision/tailoring of skin flaps, judicious intraoperative tissue expansion fills, and quilting sutures. The topical application of TXA has also been demonstrated to reduce drain outputs and decrease complications in a recent double-blind, randomized controlled trial ( 47 ).…”

A Study on Tranexamic Acid Role for Seroma Reduction in Ventral Hernia Repair

“…Firstly, TXA's ability to control bleeding may indirectly contribute to seroma reduction. Minimizing blood loss during surgery may result in less blood and associated inflammatory mediators accumulating at the surgical site, which could decrease seroma formation (Safran, 2022;Tarar et al, 2023). Seroma formation is a common complication of ventral hernia repair that can lead to discomfort, delayed wound healing, and other complications.…”

Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind Randomized Controlled Trial

“…We read the article entitled “Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind Randomized Controlled Trial,” by Safran et al, 1 with great interest. Given the scarcity of prospective studies on this subject, we commend the authors for conducting this double-blinded, randomized controlled trial.…”