Ecchymosis; Eyelid, Edema
Conditions
Keywords
Tranexamic acid, Post-operative ecchymosis, Post-operative edema
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.
Interventions
DRUGTranexamic acid injection
Tranexamic acid (100 mg/mL concentration; 0.5 mL) will be added to local anesthetic mixture of 2% lidocaine with epinephrine (2.25 mL) and 0.5% bupivacaine with epinephrine (2.25mL).
Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).
Sponsors
Consultants in Ophthalmic and Facial Plastics Surgery
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative edema/ecchymosis | 1st post op visit: post-op day 1 to 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | 1st post op visit: post-op day 1 to 3 | Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis |
Countries
United States
Contacts
Primary ContactThai Do, MD
Outcome results
None listed