The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid 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.
Brief Title
The Effect of Local Tranexamic Acid on Post-operative 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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
248-357-5100
Central Contact Email
tdo@facialworks.com
Completion Date
Completion Date Type
Estimated
Conditions
Edema
Ecchymosis; Eyelid
Eligibility Criteria
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
Inclusion Criteria
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

Gender
All
Gender Based
false
Keywords
Tranexamic acid
Post-operative ecchymosis
Post-operative edema
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04951128
Org Class
Other
Org Full Name
Consultants in Ophthalmic and Facial Plastics Surgery
Org Study Id
Tranexamic Acid
Overall Status
Unknown status
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
Primary Outcomes
Outcome Description
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
Outcome Measure
Post-operative edema/ecchymosis
Outcome Time Frame
1st post op visit: post-op day 1 to 3
Outcome Description
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
Outcome Measure
Post-operative edema/ecchymosis
Outcome Time Frame
2nd post op visit: post-op day 7 to 10
Secondary Outcomes
Outcome Description
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
Outcome Time Frame
1st post op visit: post-op day 1 to 3
Outcome Measure
Post-operative complications
Outcome Description
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
Outcome Time Frame
2nd post op visit: post-op day 7 to 10
Outcome Measure
Post-operative complications
Start Date
Start Date Type
Estimated
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anne Barmettler
Investigator Email
abarmett@montefiore.org