"Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Total Postoperative Drain Output
研究概览
简要总结
Seroma (a collection of fluid under the skin) is a common problem after breast cancer surgery, especially after modified radical mastectomy (MRM), where lymph nodes from the armpit are also removed. This can happen because surgery may damage small blood and lymph vessels. Doctors use different methods to reduce this fluid buildup, such as special glues, drains, and stitching techniques, but results are not always the same.
Tranexamic acid (TXA) is an affordable medicine that can help reduce bleeding, bruising, and fluid collection after surgery. A study at Mayo Hospital (2023-2024) looked at whether applying TXA directly to the surgical wound, along with a stitching method called flap fixation, could improve healing after breast cancer surgery.
In this study, 62 patients were divided into two groups. One group received TXA in the wound plus flap fixation, while the other group had flap fixation only. Researchers compared wound infection rates and the amount of fluid collected after surgery.
The results showed that using TXA with flap fixation significantly reduced fluid collection (seroma) and wound infection. This method is safe, simple, and cost-effective, and may help improve recovery for patients undergoing breast cancer surgery.
详细描述
Seroma is invariably associated with breast cancer surgery and is a recurring, problematic issue that has affected large number of patients. MRM in patients having locally advanced breast cancer has raised serious questions about the methods of prevention and management of subsequent seroma as axillary dissection is a strong risk factor for seroma formation, most likely damaging blood and lymphatic vessels. Various methods like topical fibrin sealants, suction drainage and quilting have been used to reduce its incidence with variable outcomes. Topical tranexamic acid (TXA) was demonstrated as a unique and inexpensive pharmacologic agent capable of decreasing blood loss, hematoma, seroma, and bruising among various general surgical and reconstructive procedures.
A study was conducted to assess the impact of applying tranexamic acid topically in combination with flap fixation on wound outcomes in patients undergoing MRM for breast cancer, focusing on the incidence of surgical site infections and the volume of postoperative drainage on surgical floor, of Mayo Hospital from 2023 to 2024.
After taking approval from ethical committee a total of 62 patients were selected as per inclusion criteria. The patients were randomized into two groups i.e. Group A patients underwent topical application of tranexamic acid along with flap fixation in mastectomy wound. While in group B patients, mastectomy wound was closed without topical application of tranexamic acid with flap fixation.
Data was entered in SPSS 26 version. Comparative analysis of two groups, Group A (with topical tranexamic acid application along with Flap Fixation) and Group B (without topical tranexamic acid application along with Flap Fixation) was done by applying chi-square test for wound infection and independent t-test for drain volume. P value <0.05 will be considered important.
Topical application of tranexamic acid, along with flap fixation has been found to decrease seroma formation and surgical site infection to a significant extent. Not only is this technique cost-effective but it is also easily applicable in patients with breast cancer who are scheduled to undergo MRM.
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
- None
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
- •all females.
- •Age more than 18 Years
排除标准
- •high risk of thromboembolism requiring anti-coagulant in perioperative period
- •known allergy to Tranexamic acid documented in history
- •patients requiring delayed wound closure after MRM
- •wound edge necrosis documented on examination postoperatively
- •preoperative involvement of muscle and bone and less than R0 resection.
研究组 & 干预措施
Group A: Received topical tranexamic acid (TXA) along with flap fixation.
Arm 1 - Experimental Arm:
Participants undergoing modified radical mastectomy (MRM) received topical tranexamic acid (TXA) applied to the surgical wound along with flap fixation at the time of wound closure to reduce postoperative seroma formation, drainage volume, and surgical site infection.
干预措施: Tranexamic Acid (Topical Application in Mastectomy Wound) (Drug)
Arm 2: Active Comparator - Flap Fixation Only
Participants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day.
干预措施: flap fixation (Procedure)
结局指标
主要结局
Total Postoperative Drain Output
时间窗: Measured from the day of surgery until drain removal days after surgery.
Total volume of fluid collected from the surgical drain following modified radical mastectomy. Drain output was measured in millilitres (mL) using calibrated closed suction drainage containers placed at the operative site. The cumulative volume recorded was documented for each participant.
次要结局
- Incidence of Surgical Site Infection(Within 30 days postoperatively)
- Incidence of Postoperative Seroma Formation(Within 30 days after surgery)
研究者
Noor ul Ain
assistant professor of surgery
King Edward Medical University