跳至主要内容
临床试验/NCT00910052
NCT00910052已完成不适用

Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial

Hennepin County Medical Center, Minneapolis2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2003年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
141
试验地点
2
主要终点
presence of postoperative fluid collection

研究概览

简要总结

Background: Post-operative wound complications arise in as many as 50% of kidney transplant recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the accumulation of post-operative fluid collections with varying success. The use of fibrin products has been proposed as a means of reducing local wound complications in the immunocompromised renal transplant recipient but as yet has not been studied.

Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or not at the time of their renal transplant. Patients were analyzed per the randomization assignment. The operating team was blinded to the decision until after the iliac fossa dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound. Patients in whom the peritoneum was entered were excluded from data analysis. The incidence of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by necessitating incision and drainage, and urine leak was recorded.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • All renal transplant recipients

排除标准

  • Patients declining study

结局指标

主要结局

presence of postoperative fluid collection

次要结局

  • wound infection
  • wound dehiscence

研究者

发起方
Hennepin County Medical Center, Minneapolis
申办方类型
Other

研究点 (2)

Loading locations...

相似试验