Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post-operative drainage volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with Primary Breast Augmentation
排除标准
- •Past History of Thromboembolism
- •Use of anticoagulant or platelet-inhibiting drugs
- •Severe Co-morbidity (ASA III)
- •Pre-pectoral Implant Pocket Location
- •Breast lipofecting
结局指标
主要结局
Post-operative drainage volume
时间窗: Through study completion, an average of 2 years.
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).
次要结局
- Post-operative complications(Through study completion, an average of 2 years.)
