Intravenous Tranexamic Acid During Rhytidectomy

Glasgold Group Plastic Surgery40 enrolled

Overview

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Bleeding Bruising Face Swelling Lips & Face

Interventions

Tranexamic Acid 100Mg/Ml Inj Vil 10MlDRUG

IV TXA given during surgery

Normal Saline 0.9% Infusion Solution BagDRUG

IV saline given during surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery Exclusion Criteria: * History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference

Locations (1)

Glasgold Group Plastic Surgery

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Intraoperative bleeding

Subjective measure of intraoperative blood loss (mild, moderate, or severe)

Time frame: Surgical time

Postoperative ecchymosis

Subjective measure of bruising rated as mild, moderate, or severe

Time frame: Postoperative day 1

Postoperative ecchymosis

Subjective measure of bruising rated as mild, moderate, or severe

Time frame: Postoperative day 6

Postoperative ecchymosis

Subjective measure of bruising rated as mild, moderate, or severe

Time frame: Postoperative day 9

Postoperative edema

Subjective measure of swelling rated as mild, moderate, or severe

Time frame: Postoperative day 1

Postoperative edema

Subjective measure of swelling rated as mild, moderate, or severe

Time frame: Postoperative day 6

Postoperative edema

Subjective measure of swelling rated as mild, moderate, or severe

Time frame: Postoperative day 9

Secondary Outcomes

Postoperative hematoma/seroma

Documentation of any postoperative collections seen during the first 10 days following surgery

Time frame: 10 days postoperative

Central Contacts

Mark J Glasgold, MD

CONTACT

732-846-6540 mglasgold@gmail.com

Justin C Cohen, MD

CONTACT

732-846-6540 justinccohen@gmail.com

Data from ClinicalTrials.gov

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