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

Plastic Surgery Clinical Trial

— DRAINAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364569
• Other study ID #: CHRD2315
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: April 1, 2016

Study information

• Verified date: July 2019
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Plastic Surgery

Intervention

Procedure:
• Tranexamic acid
Participants with taking tranexamic acid (2 x 1g per day) as a preventive and without adjuvant treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.