Patients undergoing bilateral mastectomies with immediate direct to implant reconstruction (n= 53, representing 106 breasts).
Intervention
Tranexamic acid (TXA).
Comparison
Normal saline.
Outcome
After randomization, TXA was placed in the right breast in 56.6% (n= 30) of patients. The use of topical TXA resulted in a mean drain output reduction of 30.5% (Range: -83.6% - 26.6%). Drains on the TXA treated breast were eligible for removal 1.4 (Range: 0 - 4) days sooner than the control side. TXA treated group had three complications (5.67%) versus 15 (28.3%) in the normal saline group (Odds Ratio: 0.1920). Specifically, for operative haematomas, the TXA group had none (0%) versus three in the normal saline group (5.7%), (Odds Ratio: 0.1348).
Abstract
BACKGROUND Excess fluid accumulation (seroma/hematoma) around the breast implant post reconstruction can lead to significant complications. Topical administration of tranexamic acid (TXA) may reduce fluid accumulation and reduce post-operative complications. This trial aims to investigate if TXA treated mastectomy pockets will exhibit less postoperative fluid production and complications. METHODS This paired, double-blinded, randomized-controlled trial enrolled patients undergoing bilateral mastectomies with
immediate direct to implant reconstruction. In each patient, one breast was randomized to receive 3g TXA (100cc), and the other received 100cc of NS. The blinded solutions were soaked in the mastectomy pocket for five minutes before implant placement. Postoperatively, daily drain outputs, complications, and baseline demographics were recorded. RESULTS 53 eligible patients, representing 106 breasts, were enrolled. All patients underwent bilateral nipple-sparing mastectomies. After randomization, TXA was placed in the right breast in 56.6% (n=30) of patients. The use of topical TXA resulted in a mean drain output reduction of 30.5% (RANGE -83.6% - 26.6%). Drains on the TXA treated breast were eligible for removal 1.4(RANGE 0-4) days sooner than the control side. TXA treated group had three complications (5.67%) versus 15 (28.3%) in the control group (Odds Ratio: 0.1920, p= 0.0129). Specifically, for operative hematomas, the TXA group had none(0%) versus three in the control group (5.7%)(Odds Ratio: 0.1348, P=0.18). CONCLUSION 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.
