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

Phase 4

• Conditions: Edema; Ecchymosis; Eyelid
• Interventions: Drug: Tranexamic acid injection; Other: Local anesthetic control

• Registration Number: NCT04951128
• Lead Sponsor: Consultants in Ophthalmic and Facial Plastics Surgery

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-06-27
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Study Start: 2021-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranexamic acid arm	Tranexamic acid injection	Eyelid(s) that received tranexamic acid in the local anesthetic
Control	Local anesthetic control	Eyelid(s) that receive local anesthetic without tranexamic acid

Primary Outcome Measures

Name	Time	Method
Post-operative edema/ecchymosis	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)

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	2nd post op visit: post-op day 7 to 10	Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis

Trial Locations

Locations (4)

Consultants in Ophthalmic and Facial Plastic Surgery; 🇺🇸 Southfield, Michigan, United States

University of Texas - Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States