Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
Condition: Plastic Surgery
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Procedure
Intervention description(s): Participants with taking tranexamic acid (2 x 1g per day) as a preventive and without adjuvant treatment.
Intervention MeSH terms: Tranexamic Acid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Breast augmentation with placement of prosthetic implants.
      
Keywords: Drainage; Breast augmentation; Tranexamic acid