Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants. (DRAINAGE)

Tranexamic acid (TXA), as an antifibrinolytic agent, has shown a tremendous interest in surgery by reducing blood loss ; but only few articles have been reported in the plastic surgery scope. The aim of this study was to investigate whether oral administration of TXA reduces surgical drainage in primary breast augmentation using implants.

Study Overview

• Status: Completed
• Conditions: Plastic Surgery
• Intervention / Treatment: Procedure: Tranexamic acid

Detailed Description

A total of forty participants were included in this case-control study over a fifteen months period. The participants were divided in two equal groups. The case group (TXA group) was treated with a daily oral administration of two grams of tranexamic acid whereas the control group (noTXA group) was not treated. The data that has been recorded is the gender, the age, the implant volume (cc), the shape of the implant (round or anatomical), the type of surgical pocket (pre-muscular or retro-muscular), the texture of the implant (textured or smooth), the operating time (in minutes), the blood pressure operative average during surgery, volume of fluid daily (right and left) and complications (hematoma, infection, deep vein thrombosis, pulmonary embolism, anaphylaxis and early exposure to implants).

Three investigators were enrolled in the study, including the corresponding author. Two investigators performed the intervention, operating one breast each.

At the end of the surgical procedure, a drain was put in the retro-pectoral space on each breast side. A compressive garment was immediately fitted before the exit of the participant. The participants received oral analgesics according to the hospital guidelines and no thromboprophylaxis was given, as it is a standard recommendation of the French Society of Anaesthesiologists (SFAR).

Oral administration of the TXA had never been tested in breast augmentation indications, and the investigators followed the recommendations of one gram, two times a day, starting at the end of the surgery so as to avoid any adverse effects. The participants received two grams of Spotof ® (C.C.D laboratory, Portugal) as an oral liquid solution during three days.

All participants were interviewed by a nurse every four hours starting at the end of the post-operative recovery room till the exit of their hospital stay. Drain fluid volume in the vacuum devices was recorded every twenty four hours. The drains were removed when production was below forty milliliter per twenty four hours, according to hospital routine. Any early (less than seven days) or late (better than thirty days) post-operative complications were also listed. All participants had a consultation seven days and two months after the surgery according to the department guidelines. A hotline telephone number has been given to participants to facilitate contact if any inconvenient consequences have occurred.

In each sub-group (no TXA and TXA), the main outcome was the drain fluid production during the study which was registered for each breast every twenty four hours after the surgery and at the exit of the participant. Volume were stored and collected in milli-liters (mL) without consistency or color analysis. The age (in years), the implant volume (in milliliters), the shape (round or anatomic) and the texture (smooth or textured), the mean operative time (in minutes), the mean operative arterial pressure (in mmHg) were also recorded as well as the length of the hospital stay (in days). Any surgical complications and any side effects associated to the TXA drug were also listed.

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breast augmentation with placement of prosthetic implants.

Description

Inclusion Criteria:

• Woman with Primary Breast Augmentation

Exclusion Criteria:

• Past History of Thromboembolism
• Use of anticoagulant or platelet-inhibiting drugs
• Severe Co-morbidity (ASA III)
• Pre-pectoral Implant Pocket Location
• Breast lipofecting

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participant with tranexamic acid.; The investigators followed the recommendations of one gram, two times a day, starting at the end of the surgery so as to avoid any adverse effects. The participants received two grams of Spotof ® (C.C.D laboratory, Portugal) as an oral liquid solution during three days.	Procedure: Tranexamic acid; Participants with taking tranexamic acid (2 x 1g per day) as a preventive and without adjuvant treatment.
Participant without tranexamic acid.; This group concerns participants followed without acid tranexamic treatment. Investigators will observe the postoperative practices and complications observed, according to the surgical habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative drainage volume	At the end of the surgical procedure, a drain was put in the retro-pectoral space on each breast side. A compressive garment was immediately fitted before the exit of the patient. The participants received oral analgesics according to the hospital guidelines and no thromboprophylaxis was given, as it is a standard recommendation of the French Society of Anaesthesiologists (SFAR). Drain fluid volume in the vacuum devices was recorded every 24 hours. The drains were removed when production was below 40 mL per 24h, according to hospital routine. Volume were stored and collected in milli-liters (mL) without consistency or color analysis. Age (in Years), Implant Volume (in milli-liters), Shape (Round or Anatomic) and Texture (Smooth or Textured), Mean Operative Time (in minutes), Mean Operative Arterial Pressure (in mmHg) were also recorded as well as the length of the Hospital Stay (in Days).	Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	The investigators observed postoperative complications. All participant were interviewed by a nurse every 4 hours starting at the end of the post-operative recovery room till the exit of their hospital stay. Any early (< 7 days) or late (> 30 days) post-operative complications were also listed. All the participants had a consultation 7 days and 2 months after the surgery according to the department guidelines. A Hotline phone number was given to the patients to ease contact if any inconvenient aftermath occured. Any surgical complications and any side effects associated to the TXA drug were also listed.	Through study completion, an average of 2 years.

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Thomas COLSON, Centre Hospitalier Rene Dubos

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Drainage; Tranexamic acid; Breast augmentation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: CHRD2315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No