Plastic Surgery Clinical Trial
Official title:
Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
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.
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.
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