The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Total drain output per breast per 24 hours post-surgery (mL) until drain removal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IV TXA + Topical TXA
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with topical TXA administered through the surgical drain.
干预措施: IV TXA (Drug)
IV TXA + Topical TXA
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with topical TXA administered through the surgical drain.
干预措施: Topical TXA (Drug)
IV TXA + Topical Saline
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.
干预措施: IV TXA (Drug)
IV TXA + Topical Saline
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.
干预措施: Topical saline (Drug)
No IV TXA + Topical TXA
Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with TXA administered through the surgical drain.
干预措施: Topical TXA (Drug)
No IV TXA + Topical Saline
Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.
干预措施: Topical saline (Drug)
结局指标
主要结局
Total drain output per breast per 24 hours post-surgery (mL) until drain removal
时间窗: From date of operation until drain removal up to 4 weeks.
Drain outputs will be recorded separately for each breast twice daily until removal.
Time to drain removal (days)
时间窗: From date of operation until drain removal up to 4 weeks.
Drains will be removed per standard protocol by trained staff if the output is ≤30 mL in a 24-hour period for two consecutive days. The time to drain removal will be recorded.
次要结局
- Wound Dehiscence Rate(From date of surgery until end of study (30 days postoperative).)
- 30-Day Readmission Rate(From date of surgery until end of study (30 days postoperative))
- Patient-Reported Outcomes (BREAST-Q Breast Reduction Module)(Preoperative before surgery, 7 days after and 30 days after surgery.)
- Length of Hospital Stay(From date of surgery until discharge from the hospital up to 4 weeks.)
- Change in drain fluid color from bloody to serous until drain removal assessed by daily observation(From postoperative Day 1 until drain removal, up to 4 weeks after surgery)
- Seroma Rate(From date of surgery until end of study (30 days postoperative).)
- Infection Rate(From date of surgery until end of study (30 days postoperative).)
- Hematoma Rate(From date of surgery until end of study (30 days postoperative).)
- 30-Day Revision Rate(From date of surgery until end of study (30 days postoperative).)
研究者
Katherine Carruthers
MD, MS, Primary Investigator, Assistant Professor, Division of Plastic and Reconstructive Surgery, Department of Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, MA
Massachusetts General Hospital