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临床试验/CTRI/2024/12/077847
CTRI/2024/12/077847尚未招募4 期

Effect of topical tranexamic acid in reducing axillary drain output post modified radical mastectomy Surgery

Pradeep Kumar Singh1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
to study the effects of topical tranexamic acid application on

研究概览

简要总结

Breast cancer is one of the most common cancer being diagnosed in women which accounts for more than 1 in 10 new cancer diagnosed every year. It is the second most common cause of death from cancer among women in the world. The most common procedure used at present is the modified radical mastectomy. One of the major complications associated with Modified radical mastectomy is seroma formation with the incidence rate reaching up to 18% which leads to delayed drain removal and increased hospital stay. Duration of surgery is directly associated with an increased risk of seroma formation. Factors like the level of lymph nodes and tumor size have been inconclusive in establishing an association with seroma formation. This study aims to study the role of tranexamic acid on this very common but important side effect of a very commonly performed surgery. Tranexamic acid is a synthetic derivative of lysine that blocks lysine binding sites on plasminogen which inhibits plasminogen thereby leading to reduced formation of plasmin. This leads to an overall reduction in fibrinolysis and reduction in blood loss. Seroma formation is related to local fibrinolytic activity, Being an anti-fibrinolytic, the local application of tranexamic acid looks promising in reducing seroma formation. Some studies have shown local application of tranexamic acid has equal efficacy as compared to IV administration for reduction in blood loss and better bone healing and granulation. The safety profile of Tranexamic acid remains in question due to a potential increased risk of venous thromboembolism. By applying TXA topically as opposed to intravenously, systemic absorption may be reduced and unwanted side effects mitigated. Tranexamic acid has immunomodulatory action independent of its action on plasminogen. This action of tranexamic acid can be correlated with surgical site infection rates. Tranexamic acid directly reduces fibrinolytic activity and hence modified radical mastectomy is a good choice of surgery to study the topical effect of Tranexamic acid.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • All patients above 18 years of age diagnosed with breast carcinoma undergoing modified radical mastectomy.

排除标准

  • Pregnancy Patients with known thromboembolic disease Patients not giving consent or not understanding the nature of the study.

结局指标

主要结局

to study the effects of topical tranexamic acid application on

时间窗: Daily drain output will be measured. The drain will be removed on the day when the daily drain output recorded will be less than 30ml on two consecutive days.

axillary drain output post modified radical mastectomy

时间窗: Daily drain output will be measured. The drain will be removed on the day when the daily drain output recorded will be less than 30ml on two consecutive days.

次要结局

  • Incidence of seroma formation after drain removal at the end of three months(Incidence of surgical site infection at day 30 after MRM)

研究者

发起方
Pradeep Kumar Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pradeep Kumar Singh

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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