Intraoperative Microbial Contamination, Its Prevention and Its Consequences for Outcomes Following Joint Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,661
- 试验地点
- 6
- 主要终点
- Does Ioban prevent intraoperative microbial contamination?
研究概览
简要总结
This is a randomized, controlled study which aims to show whether iodine impregnated incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI). 1200 patients will be included in this study and will be followed through out a ten year period.
Follow up will center on the function of the prosthetic knee, early and late infection rates and revision surgery due to aseptic loosening.
Our purpose is to gain insight in to the causes of post-operative infection in joint alloplasty surgery. Our hypothesis' are:
- The patient's skin flora is the main source of intraoperative contamination,
- Intraoperative contamination can be reduced by using IobanTM
- Intraoperative contamination strongly predicts postoperative infection
- Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections.
To our knowledge this is the first study with this large a sample size and as long a follow up.
Background PJI is a devastating complication with substantial morbidity and high socio economic costs. Revision surgery due to infection costs as much as six times more than the primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of function.
Methods and materials
The study has two main arms:
- Intraoperative contamination
- Postoperative infection
The first stage aims to document that patients with intraoperative contamination have a larger risk of developing postoperative infection and include a study of the effect of Ioban™.
The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence microscopy, to demonstrate bacterial contamination and/or infection of any implants removed during the study period.
Perspectives This study will give us new insight in the causes of PJI and the correlation with contamination during surgery. If IobanTM is proved to prevent infection it is a simple way to prevent post-operative infection and can be implemented in any orthopedic department.
详细描述
Introduction Approximately 8,000 primary knee arthroplasty procedures are performed annually at Danish hospitals (1). Infection is a serious complication that occurs with a frequency of around 2 %.
A mean of hindering infection is the use of IobanTM, an incisional drape impregnated with iodine. This costs 69 DKK pr. sheet. A two-stage stage operation for infection costs 253,122 DKK. (2) Using IobanTM for 8000 knee operations costs 552,000 DKK. Besides high socio economic costs infections cause considerable morbidity and have severe consequences for the independent mobility of the patient (3-5).
As the estimated number of arthroplasty procedures continuously increase so will the number of infections (6), and prevention is therefore of high priority.
Aim
The inestigators' purpose is to gain insight in to the causes of post-operative infection in joint arthroplasty surgery. The investigators' hypothesis' are:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of 18 years of age or older scheduled for primary knee arthroplasty surgery will be eligible for inclusion in the study
排除标准
- •known allergy or hypersensitivity to iodine or adhesive drape
- •history of infection in the knee (e.g. septic arthritis, osteomyelitis)
- •active infection at another site at the time of surgery
- •antibiotic use within 4 weeks before surgery
- •previous enrolment in the study.
研究组 & 干预措施
Ioban
In this arm patients will be operated using Ioban as incisional drape.
干预措施: Ioban (Device)
Control
In this arm patients will be operated using no incisional drape.
结局指标
主要结局
Does Ioban prevent intraoperative microbial contamination?
时间窗: approximately 2 hours. Sampling is done during surgery.
A randomized controlled study is performed to determine the effect of iodine impregnated incisional drape on intraoperative contamination. The primary outcome is the frequency of intraoperative contamination in the projects' two arms.
Sources of intraoperative contamination
时间窗: approximately 2 hours. Sampling is done during surgery.
A prospective study is performed to assess the frequency of intraoperative contamination. During standard knee arthroplasty surgeries the samples are obtained. Three swabs, (Copan ESwab) will be taken during surgery. The first swab is taken from the skin of the surgical site prior to skin preparation. The second swab just after incision and will be of the wound edges. Intra-operative contaminants are cultured from the glove of the surgeon's dominant hand using a special glove culture technique with samples taken 30 minutes after skin incision (or before changing gloves when handling implants or using bone cement impregnated with antibiotics - whichever comes first) and the third swab is taken from the skin edges after closure of the subcutaneous tissue before closure of the skin. All the samples will be cultured and undergo susceptability testing. Analysis will determine the most frequent source of contamination.
次要结局
- Postoperative infections are caused (are not caused) by intra-operative contamination.(Approximately 4 hours. Sampling done during revision surgery)
研究者
Anne Brun Hesselvig
MD, Primary Investigator
University of Copenhagen