Hematoma Postoperative, Venous Thromboembolism
Conditions
Keywords
breast reduction mammoplasty, hematoma, tranexamic acid
Brief summary
Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes. Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.
Detailed description
Prevention of perioperative blood loss is a chief consideration in plastic surgery. Breast reduction mammoplasty (BRM) is one of the most commonly performed procedures in plastic surgery, with over 100,000 performed in the United States in 2019 alone. Postoperative hematomas are among the most frequent complications following BRM, with a reported incidence between 0.3-7% in the literature. Many of these hematomas require blood transfusions and/or urgent surgical evacuation to avoid the consequent wound healing issues arising from increased tension on the closure. Tranexamic acid (TXA) has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. TXA is an antifibrinolytic agent that acts by stabilizing clot formation, and may be administered intravenously, orally, or topically. Topical administration of TXA has been shown to be as efficacious as intravenous dosing, though with substantially less systemic absorption. Multiple randomized controlled trials have demonstrated that TXA significantly reduces intraoperative bleeding and need for subsequent blood transfusion, without an increased risk of thromboembolic events. Moreover, TXA has been shown to be cost-effective in the surgical setting, not only by reducing direct hospital costs (drug and blood products), but also by decreasing subsequent costs by shortening length of stay and lowering the incidence of complications. However, the use of TXA in plastic surgery has not been well described. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of TXA in patients undergoing BRM. The primary outcome variable will be the rate of hematoma development. The secondary outcome variables will be the incidence of blood transfusion and the incidence of thromboembolic events. The investigators will also collect a broad range of preoperative variables, surgical details, and other characteristics that may impact the perioperative bleeding risk. All patients eligible for reduction mammoplasty between July 1, 2021 and June 30, 2022 will be included in this study. The investigators hypothesize that use of TXA will decrease total perioperative blood loss, hematoma formation, and transfusion rates following reduction mammoplasty without increasing the incidence of thromboembolic events. Better understanding of the effect of TXA in reduction mammoplasty may be of great utility to the field of plastic surgery.
Interventions
Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
The untreated breast will receive topical saline.
Sponsors
Study design
Masking description
The patient and the surgical team will be blinded to which breast has received the study drug
Intervention model description
Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast
Eligibility
Inclusion criteria
* Being over the age of 18 * Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York
Exclusion criteria
* Oncologic breast reduction * Unilateral breast reduction * History of thromboembolic disease * History of bleeding diatheses * History of stroke * History of seizure disorder * Currently pregnant * Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness grade IV or above)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breasts With Development of Hematoma | Up to 30 days | The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring a Blood Transfusion | Up to 30 days | The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level |
| Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism | Up to 30 days | Incidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan) |
Countries
United States
Participant flow
Pre-assignment details
Patients undergoing bilateral reduction mammoplasty were enrolled in this study. One breast was randomized to receive the treatment, the other received a placebo; therefore, there were 98 patients enrolled and 196 treated breasts.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline) Each patient undergoing routine bilateral breast reduction was randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast received topical saline.
Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
OR
Placebo (topical saline): The untreated breast will receive topical saline. | 98 |
| Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline) Each patient undergoing routine bilateral breast reduction was randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast received topical saline.
Treatment: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
OR
Placebo (topical saline): The untreated breast will receive topical saline. | 196 |
| Total | 294 |
Baseline characteristics
| Characteristic | Treatment Side (Tranexamic Acid) or Placebo Side (Topical Saline) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants |
| Age, Continuous | 34.14 years STANDARD_DEVIATION 12.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 57 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 98 participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 98 |
| other Total, other adverse events | 0 / 98 | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 |
Outcome results
Number of Breasts With Development of Hematoma
The number of breasts with clinically significant hematoma (collection of blood under the skin) requiring either conservative management or operative washout was determined.
Time frame: Up to 30 days
Population: One of the two breasts was randomized to receive the study drug, the other breast was randomized to receive saline. As all participants had a bilateral operation performed, there were 196 analyzed units for 98 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Side (Right or Left) | Number of Breasts With Development of Hematoma | 2 breasts |
| Placebo Side (Right or Left) | Number of Breasts With Development of Hematoma | 1 breasts |
Number of Participants Requiring a Blood Transfusion
The number of participants requiring blood transfusion was based on the postoperative decline in hematocrit level
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Side (Right or Left) | Number of Participants Requiring a Blood Transfusion | 0 Participants |
| Placebo Side (Right or Left) | Number of Participants Requiring a Blood Transfusion | 0 Participants |
Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism
Incidence of clinically significant deep vein thrombosis or pulmonary embolism detected on imaging (ultrasound or CT scan)
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Side (Right or Left) | Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism | 0 Participants |
| Placebo Side (Right or Left) | Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism | 0 Participants |