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临床试验/NCT01538173
NCT01538173已完成4 期

Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty

Max Dieterich1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Application of twice a day 250ml HES 6% for three days postoperatively.

干预措施: 250ml HES 6% (Drug)

NaCl group

Active Comparator

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

发起方
Max Dieterich
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Max Dieterich

Principle investigator

University of Rostock

研究点 (1)

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