From the Division of Plastic and Reconstructive Surgery, McGill University Health Center.
Division of Plastic and Reconstructive Surgery, Jewish General Hospital.
Plast Reconstr Surg. 2023 Oct 1;152(4):699-706. doi: 10.1097/PRS.0000000000010322. Epub 2023 Feb 27.
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.
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.
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).
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.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
乳房重建后假体周围的积液（血清肿/血肿）可导致严重并发症。局部应用氨甲环酸（TXA）可减少液体积聚并减少术后并发症。本试验旨在研究 TXA 处理的乳房切除术袋是否会表现出更少的术后液体生成和并发症。
这项配对、双盲、随机、对照试验纳入了双侧乳房切除术和即刻直接植入重建的患者。在每位患者中，一侧乳房随机接受 3 g TXA（100 cc），另一侧接受 100 cc 生理盐水。在放置植入物之前，将盲法溶液浸泡在乳房切除袋中 5 分钟。术后记录每日引流量、并发症和基线人口统计学资料。
53 名符合条件的患者（106 例乳房）入组。所有患者均行双侧保留乳头的乳房切除术。随机分组后，30 例患者（56.6%）右侧乳房使用 TXA。局部使用 TXA 可使引流量平均减少 30.5%（范围，-83.6%至 26.6%）。TXA 治疗侧的引流管可提前 1.4 天（范围，0 至 4 天）取出，比对照组更快。TXA 治疗组有 3 例（5.67%）并发症，对照组有 15 例（28.3%）（OR，0.1920；P=0.0129）。具体来说，对于手术性血肿，TXA 组无（0%），对照组有 3 例（5.7%）（OR，0.1348；P=0.18）。
在植入物插入前用 3%局部 TXA 浸泡乳房切除术床可减少引流量并减少并发症。局部应用 TXA 是减少所有oplastic 乳房重建并发症的一种选择。
临床问题/证据水平：治疗性，I 级。
