A Clinical Study to Evaluate the Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Presence/absence of leg wound infection, General wound healing - picture evaluation
研究概览
简要总结
The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation.
This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.
详细描述
Postoperative wound disturbances, particularly surgical site infection of the chest and leg incision site following cardiac surgery are associated with increased morbidity, mortality, and costs. A recent dissertation from the National hospital in Norway showed a 20% infection rate in wounds after bypass surgery, this is probably representable nation wide. Prophylactic interventions that reduce postoperative wound disturbances and infection would have inherent value in cardiothoracic surgery. Ideally, a specific intervention would demonstrate improved patient outcomes while reducing the output of hospital resources.
The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation. It is hypothesized that the elevated cytokine levels will elucidate an accelerated healing response of the affected tissue. PPP application has also been advocated as a tissue sealant for topical hemostasis.
This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing a cardiothoracic procedure requiring a leg vein harvest
- •Patient signature of informed consent form
排除标准
- •Pregnancy
- •< 18 years of age
- •History of amenia (hemoglobin < 11.0)
- •History of bleeding disorder
- •Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- •Hypothyroidism
- •History of any blood disorder
- •Patient with an active infection
- •Patients taking Cox II inhibitors.
- •Heparin-induced thrombocytopenia
结局指标
主要结局
Presence/absence of leg wound infection, General wound healing - picture evaluation
时间窗: 6 weeks
次要结局
- ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control(6 weeks)
