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

Primary Purpose

Edema, Ecchymosis; Eyelid

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid injection
Local anesthetic control
Sponsored by
Consultants in Ophthalmic and Facial Plastics Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edema focused on measuring Tranexamic acid, Post-operative ecchymosis, Post-operative edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Consultants in Ophthalmic and Facial Plastic Surgery
  • Montefiore Medical Center
  • Houston Methodist
  • University of Texas - Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tranexamic acid arm

Control

Arm Description

Eyelid(s) that received tranexamic acid in the local anesthetic

Eyelid(s) that receive local anesthetic without tranexamic acid

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Post-operative complications
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
Post-operative complications
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis

Full Information

First Posted
June 27, 2021
Last Updated
July 1, 2021
Sponsor
Consultants in Ophthalmic and Facial Plastics Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04951128
Brief Title
The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
Official Title
The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consultants in Ophthalmic and Facial Plastics Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Ecchymosis; Eyelid
Keywords
Tranexamic acid, Post-operative ecchymosis, Post-operative edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Randomized control trial
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid arm
Arm Type
Experimental
Arm Description
Eyelid(s) that received tranexamic acid in the local anesthetic
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Eyelid(s) that receive local anesthetic without tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Local anesthetic control
Intervention Description
Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).
Primary Outcome Measure Information:
Title
Post-operative edema/ecchymosis
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)
Time Frame
1st post op visit: post-op day 1 to 3
Title
Post-operative edema/ecchymosis
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)
Time Frame
2nd post op visit: post-op day 7 to 10
Secondary Outcome Measure Information:
Title
Post-operative complications
Description
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
Title
Post-operative complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thai Do, MD
Phone
248-357-5100
Email
tdo@facialworks.com
Facility Information:
Facility Name
Consultants in Ophthalmic and Facial Plastic Surgery
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thai Do, MD
Phone
247-357-5100
Email
tdo@facialworks.com
First Name & Middle Initial & Last Name & Degree
Dianne Schlachter, MD
First Name & Middle Initial & Last Name & Degree
Evan Black, MD
First Name & Middle Initial & Last Name & Degree
Thai Do, MD
First Name & Middle Initial & Last Name & Degree
Peter Kally, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Barmettler, MD
Phone
718-920-5561
Email
abarmett@montefiore.org
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
70030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina Malik, MD
Phone
713-441-8843
Email
almalik@houstonmethodist.org
Facility Name
University of Texas - Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Richani, MD
Phone
713-559-5200
Email
karina.richanireverol@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Daniel Jones, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

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