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

NCT03364569 | Completed

• 1 other identifier: CHRD2315
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Plastic Surgery

Keywords

Drainage; Breast augmentation; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative complications

  Through study completion, an average of 2 years.

Study Arms (2)

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

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.

Interventions

Tranexamic acid PROCEDURE

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

Participant with tranexamic acid.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Breast augmentation with placement of prosthetic implants.

You may qualify if:

• Woman with Primary Breast Augmentation

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Thomas COLSON

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 6, 2017
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share