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临床试验/NCT00514241
NCT00514241已完成1 期

A Clinical Study to Evaluate the Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery

Zimmer Biomet1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
Zimmer Biomet
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

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)

研究者

发起方
Zimmer Biomet
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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