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临床试验/NCT04951128
NCT04951128Unknown4 期

The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

Consultants in Ophthalmic and Facial Plastics Surgery4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
50
试验地点
4
主要终点
Post-operative edema/ecchymosis

研究概览

简要总结

Tranexamic acid (TXA) is a synthetic inhibitor of plasminogen lysine receptor that has used to reduce intra-operative bleeding in a number of clinical scenarios. Anecdotally, TXA has used by plastic surgeons to reduce post-operative bruising. To date, there is limited data to valid the benefits and to evaluate the side effects of TXA. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

详细描述

Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reduce bleeding. Recent studies have demonstrated the antifibrinolytic benefits of TXA in a number of clinical scenarios, including heavy menstrual bleeding, traumatic hemorrhage, elective cesarean section, total knee arthroplasty, coronary artery surgery, spinal deformity surgery, orthognathic surgery, transurethral prostate resection, aneurysmal subarachnoid hemorrhage, epistaxis, and hemoptysis.

Anecdotally, TXA has been used by plastic surgeons to reduce postoperative bruising. However, there is a paucity of clinical data on TXA use in plastic surgery, and the results are inconsistent. In a prospective randomized controlled trial evaluating local TXA in upper blepharoplasty, Sagiv et al reported no intraoperative blood loss, surgeon's assessment of hemostasis, and periocular ecchymosis size on postoperative day 1. Butz and Geldner reviewed their experience placing TXA-soaked pledgets in 57 patients who underwent face lift18. They identified only 1 patient who had post-operative hematoma and they reported no systemic complications from TXA use. In a randomized control trial evaluating topical TXA in reduction mammoplasty, Ausen et al reported 39% reduction of postoperative fluid drainage on the treatment side. In a study evaluating oral TXA and cortisone effect in rhinoplasty, Sakalliogu et al reported significant reduction of intraoperative bleeding and postoperative ecchymosis/edema in patients who underwent rhinoplasty. Further study is warranted to evaluate the use to TXA in plastic surgery. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants in this study will undergo bilateral upper/lower eyelid surgery. The treatment side with tranexamic acid will be randomized for each patient using a random coin flip generator (head for the right side and tail for left side). The surgeons, participants, and photo reviewers will be blinded to the treatment side.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years old
  • Undergo bilateral upper/lower eyelid blepharoplasty, bilateral upper eyelid ptosis repair, or a combination of the above procedures
  • Additional concurrent forehead/brow or upper/lower eyelids surgeries may be included if bilateral

排除标准

  • Prior eyelid surgery
  • Anticoagulant or antiplatelet use, including aspirin, within 7 days prior to surgery
  • Patient who is currently pregnant or breast feeding
  • Patient with color vision deficiency
  • TXA allergy
  • History of bleeding disorder
  • History of clotting disorder
  • History of seizure
  • Have active nausea/vomiting/gastrointestinal symptoms
  • Have active intracranial bleeding
  • Have active periocular ecchymosis or edema prior to surgery

研究组 & 干预措施

Tranexamic acid arm

Experimental

Eyelid(s) that received tranexamic acid in the local anesthetic

干预措施: Tranexamic acid injection (Drug)

Control

Active Comparator

Eyelid(s) that receive local anesthetic without tranexamic acid

干预措施: Local anesthetic control (Other)

结局指标

主要结局

Post-operative edema/ecchymosis

时间窗: 2nd post op visit: post-op day 7 to 10

Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)

次要结局

  • Post-operative complications(2nd post op visit: post-op day 7 to 10)

研究者

发起方
Consultants in Ophthalmic and Facial Plastics Surgery
申办方类型
Other
责任方
Sponsor

研究点 (4)

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