A Phase 4 interventional study of Tranexamic acid injection and Local anesthetic control in Edema and Ecchymosis; Eyelid, sponsored by Consultants in Ophthalmic and Facial Plastics Surgery. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Consultants in Ophthalmic and Facial Plastics Surgery · Phase 4, Interventional, and Treatment
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.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 401 interventional studies indexed under Edema.
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Exclusion Criteria:
Eyelid(s) that received tranexamic acid in the local anesthetic
Drug: Tranexamic acid injection
Eyelid(s) that receive local anesthetic without tranexamic acid
Other: Local anesthetic control
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).
Post-operative edema/ecchymosis
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
Time frame: 1st post op visit: post-op day 1 to 3
Post-operative edema/ecchymosis
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
Time frame: 2nd post op visit: post-op day 7 to 10
Post-operative complications
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
Time frame: 1st post op visit: post-op day 1 to 3
Post-operative complications
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
Time frame: 2nd post op visit: post-op day 7 to 10
Plan to share: No
Start is estimated for Aug 2021; primary completion for Dec 2021, 4 months later.
Of 28 phase 4 interventional studies under Edema, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 74. This study's planned 4 months is below that.
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid