Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Surgical side infection
研究概览
简要总结
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
详细描述
Many studies identifying risk factors for surgical side infections (SSI) after breast surgery included a large percentage of breast conserving therapies and risk factors for patients undergoing more extensive procedures like breast reduction (BR) are underrepresented and risk factors for more extensive breast surgeries might not be identified. Our approach to decrease SSI after BR was the application of an i.v. isotonic crystalloid solution, 6% hydroxyethylstaerke (HES) as a diminished peripheral blood flow and impaired vasculogenesis are characteristics of poorly healing wounds. HES causes a medium- to long-term increase in blood volume, blood flow and improved blood oxygen transport. Blood flow and tissue oxygenation are parts of regulating the healing process by utilizing molecular oxygen as a terminal oxidant. This antioxidant capacity can influence the wound healing process positively, as a characteristic feature of the inflammatory phase is the oxidative burst. HES additionally decreases haematocrite, blood viscosity and aggregation of erythrocytes positively influencing the complex components regulating wound healing. These characteristics and the increase in blood circulation might influence the postoperative healing and regeneration process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.
排除标准
- •Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery
研究组 & 干预措施
HES group
Application of twice a day 250ml HES 6% for three days postoperatively.
干预措施: 250ml HES 6% (Drug)
NaCl group
Application twice a day 500ml 9% NaCl for three days postoperatively.
干预措施: 9% NaCl 500ml (Drug)
结局指标
主要结局
Surgical side infection
时间窗: 4 weeks
Primary end point was the development of surgical side infection
次要结局
- Risk factors(4 weeks)
研究者
Max Dieterich
Principle investigator
University of Rostock
