Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery

Официальное название

The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients

Обзор

This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either intravenous TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline. This approach allows to compare the effects of TXA on fluid buildup and healing. The goal is to improve recovery and reduce complications after breast reduction surgery.

Подробное описание

This single-center, prospective, randomized controlled trial investigates the effect of tranexamic acid (TXA) on postoperative drain output and recovery following bilateral reduction mammaplasty. While TXA is widely utilized to minimize intraoperative blood loss, its role in optimizing postoperative wound healing and fluid management in plastic surgery remains underexplored.

Participants undergoing bilateral breast reduction will be randomized to receive either intravenous TXA or no TXA at the time of surgery. In addition, each breast will be independently randomized to receive TXA or saline via the closed-suction drain after skin closure. This split-body design enables a controlled intra-individual comparison of local TXA effects, while concurrently assessing systemic administration in a parallel fashion.

Primary outcomes include total drain output per breast and time to drain removal. Secondary endpoints include the incidence of postoperative hematoma and patient reported outcomes. All outcome measures will be recorded using standardized protocols and assessed by blinded evaluators where applicable.

Participants will be followed until 30 days postoperatively.

Given the established safety profile of TXA and the relatively low-risk nature of the intervention, no independent data monitoring committee has been appointed. The study has been approved by the local IRB and will adhere to institutional standards for adverse event monitoring and reporting.

Вмешательства

• Препарат IV TXA
  Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).
• Препарат Topical TXA
  Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
• Препарат Topical saline
  Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.

Первичные конечные точки

• Total drain output per breast per 24 hours post-surgery (mL) until drain removal [Срок оценки: From date of operation until drain removal up to 4 weeks.]
• Time to drain removal (days) [Срок оценки: From date of operation until drain removal up to 4 weeks.]

Вторичные конечные точки (9)

• Change in drain fluid color from bloody to serous until drain removal assessed by daily observation [Срок оценки: From postoperative Day 1 until drain removal, up to 4 weeks after surgery]
• Seroma Rate [Срок оценки: From date of surgery until end of study (30 days postoperative).]
• Infection Rate [Срок оценки: From date of surgery until end of study (30 days postoperative).]
• Hematoma Rate [Срок оценки: From date of surgery until end of study (30 days postoperative).]
• Wound Dehiscence Rate [Срок оценки: From date of surgery until end of study (30 days postoperative).]
• Length of Hospital Stay [Срок оценки: From date of surgery until discharge from the hospital up to 4 weeks.]
• 30-Day Readmission Rate [Срок оценки: From date of surgery until end of study (30 days postoperative)]
• 30-Day Revision Rate [Срок оценки: From date of surgery until end of study (30 days postoperative).]
• Patient-Reported Outcomes (BREAST-Q Breast Reduction Module) [Срок оценки: Preoperative before surgery, 7 days after and 30 days after surgery.]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Elective bilateral breast reduction
• Patient understands and is willing to participate in the study
• Patient willing to and capable of providing informed consent

Критерии исключения

• Age less than 18 years old
• Prior radiation to the breast
• Secondary/Revision breast reduction
• Known coagulopathy or bleeding disorders
• Intraoperative coagulopathy
• History of seizures
• Active smokers
• Allergy or contraindication to TXA
• Pregnant or breastfeeding patients
• Patient is unable or unwilling to complete the anticipated study follow-up
• Inability to understand the aims and objectives of the study
• Inability to or unwilling to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Публикации

• Nichols G, Andrade E, Gregoski M, Herrera FA, Armstrong MB. Local Infiltration of Tranexamic Acid in Breast Reduction for Symptomatic Macromastia. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S366-S370. doi: 10.1097/SAP.0000000000003456. Epub 2023 Feb 18. PMID 36856723
• Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878. PMID 26349843
• Safran T, Vorstenbosch J, Viezel-Mathieu A, Davison P, Dionisopoulos T. Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind Randomized Controlled Trial. Plast Reconstr Surg. 2023 Oct 1;152(4):699-706. doi: 10.1097/PRS.0000000000010322. Epub 2023 Feb 27. PMID 36827482
• Liechti R, van de Wall BJM, Hug U, Fritsche E, Franchi A. Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2023 May 1;151(5):949-957. doi: 10.1097/PRS.0000000000010071. Epub 2022 Dec 19. PMID 36729428
• Guggenheim L, Magni S, Catic A, Pagnamenta A, Harder Y, Schmauss D. The Effects of Systemic Tranexamic Acid Administration on Drainage Volume, Duration of Drain Placement, and Length of Hospital Stay in Skin- and Nipple-Sparing Mastectomies with Immediate Expander-Based Breast Reconstruction. J Clin Med. 2024 Oct 30;13(21):6507. doi: 10.3390/jcm13216507. PMID 39518646
• Zucal I, De Pellegrin L, Pagnamenta A, Schmauss D, Brucato D, De Monti M, Schweizer R, Harder Y, Parodi C. Topical Application of Tranexamic Acid in Abdominoplasties Leads to Lower Drainage Volume and Earlier Drain Removal. Plast Reconstr Surg Glob Open. 2025 May 20;13(5):e6799. doi: 10.1097/GOX.0000000000006799. eCollection 2025 May. PMID 40395663
• Fung E, Godek M, Roth JM, Montalmant KE, Yu BZ, Henderson PW. The current state of tranexamic acid in mastectomy and breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2025 May;104:259-272. doi: 10.1016/j.bjps.2025.03.022. Epub 2025 Mar 12. PMID 40156946
• Om A, Marxen T, Kebede S, Losken A. The Usage of Intravenous Tranexamic Acid in Reduction Mammaplasty Safely Reduces Hematoma Rates. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S371-S374. doi: 10.1097/SAP.0000000000003296. Epub 2022 Dec 8. PMID 36729851

Идентификаторы

NCT: NCT07131592 · 2025P001908

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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