| Registry | NCT04951128 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, single group, masking: triple, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Consultants in Ophthalmic and Facial Plastics Surgery (Other) |
| Conditions | Edema, Ecchymosis; Eyelid |
| Interventions | Tranexamic acid injection, Local anesthetic control (Drug, other) |
| Dates | start 2021-08-01 (estimated), primary completion 2021-12-31 (estimated), completion 2022-07-01 (estimated), first posted 2021-07-06, last updated 2021-07-06 |
| Locations | 4 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Edema All trials for Ecchymosis; Eyelid All trials of Tranexamic acid injection All trials of Local anesthetic control
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tranexamic acid arm | Experimental | Drug: Tranexamic acid injection | Eyelid(s) that received tranexamic acid in the local anesthetic |
| Control | Active comparator | Other: Local anesthetic control | Eyelid(s) that receive local anesthetic without tranexamic acid |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Consultants in Ophthalmic and Facial Plastic Surgery | Southfield, Michigan | United States | |
| Montefiore Medical Center | The Bronx, New York | United States | |
| Houston Methodist | Houston, Texas | United States | |
| University of Texas - Health Science Center at Houston | Houston, Texas | United States |