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临床试验/NCT01477047
NCT01477047已完成不适用

Identification of Risk Factors of Prolonged Wound Healing Following Total Hip and Knee Arthroplasty

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
1
主要终点
Wound drainage time

研究概览

简要总结

Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose of this study is to verify those findings and determine additional pharmacological, surgical and patient related factors that may result in prolonged wound drainage, prolonged hospital stay and increased risk of infection

详细描述

Study type: Prospective cohort study. Inclusion criteria: All patients receiving primary total hip or knee replacement surgery at Hvidovre Hospital from January 1st 2012 to December 31st 2014.

Exclusion criteria: none Intervention: none

New hypothesis to be tested:

  1. Hypertension is associated with prolonged wound drainage and increased risk of infection
  2. Patients receiving Statin treatment have decreased postoperative wound drainage and decreased risk of infection.
  3. Patients receiving Bisphosphonate treatment have increased postoperative wound drainage and increased risk of infection.

Measured patient related risk variables: Age, sex, primary OA diagnosis, diabetes, smoking, BMI, alcohol consumption, autoimmune disease and hypertension will all be recorded upon admission of the patient to the hospital. Hypertension will be defined when a patient is diagnosed with HT previously to the surgery, receives medical treatment and have systolic / diastolic BP above 140/90 mmHg upon admission. Patients with normal BP upon admission receiving treatment for HT will be classified as having regulated HT. Patients with elevated BP upon admission without previous HT diagnosis will be classified as having newly diagnosed HT. "Smoking" will de divided into smokers, non-smokers and former smokers. Further on, average number of cigarettes pr day during the last month will be recorded for current smokers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014.

排除标准

  • Not willing to participate.
  • Drop out at 3 week follow up.

结局指标

主要结局

Wound drainage time

时间窗: 3 weeks

次要结局

  • Clinical infection(months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirill Gromov

MD, PhD

Hvidovre University Hospital

研究点 (1)

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