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临床试验/NCT03158623
NCT03158623已完成3 期

The Effects of Platelet-Rich Plasma and Activated Collagen on Wound Healing in Primary Total Joint Arthroplasty

Salt Lake Orthopedic Clinic0 个研究点目标入组 90 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
90
主要终点
Wound Status

研究概览

简要总结

3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

详细描述

Background: Wound healing remains a concern in primary total joint arthroplasty given the risk of deep infections arising from hematomas, wound separations, and superficial infections. If wound additives can prevent these early complications, their universal application would be cost effective. This study examined whether two wound additives, Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative wound healing and reduce complications in primary total joint arthroplasty.

Methods: A prospective, randomized, controlled study using three cohorts with 30 patients each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined postoperatively at two and six weeks, at which time the following data were recorded: six wound measurements, total postoperative blood loss, complications of superficial infections, and reoperations.

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)

盲法说明

computer generated randomization

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoathritis of knee and hip

排除标准

  • Inflammatory arthritis and hypercoagulable state

结局指标

主要结局

Wound Status

时间窗: 6 weeks post operative

wound hematoma, dehiscence, superficial infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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