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临床试验/NCT05816135
NCT05816135招募中不适用

Investigation of Environmental Parameters in Operating Rooms and Their Association With Surgical Site Infections During Orthopedic Implant Related Surgeries.

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Environmental parameters association with surgical site infections

研究概览

简要总结

Postoperative surgical site infection (SSI) is a serious and complicated healthcare-associated infection (HAI) affecting about 2% of patients undergoing orthopedic surgery. Exogenous infections, could occur from insufficient air quality in operating rooms as shown in previous studies. However, from our knowledge, no study have collect environmental parameters and cross referenced the data with recorded patient registries to see if insufficient air quality is associated with higher risk of exogenous SSI. Temperature, humidity and the difference in air pressure in relation to the operating room and the adjacent corridors are examples of environmental parameters that could affect the air quality in operating rooms. Number of persons during an operation and particle counts could also give an indication of insufficient air quality.

详细描述

Postoperative surgical site infection (SSI) is a serious and complicated healthcare-associated infection (HAI) affecting about 2% of patients undergoing orthopedic surgery. The source of the SSI can be the patient's own bacteria, which have entered the wound e.g. via the bloodstream or the skin, giving rise to so called endogenous infection. Exogenous infection is instead when the wound is contaminated from an external source, e.g. from skin particles shredded from the operating personnel or from other airborne bacterial- containing particles that end up directly in the wound of the patient. The particles can also fall on surfaces causing indirect wound contamination via surgical instruments or via the surgeon's hands. The consequences of SSI are usually greatest when a foreign body, such as an implant, has been placed into the patient's body. The foreign material gives the bacteria a surface to attach to and to form biofilm on, which protects the bacteria against both the body's immune system and antibiotic treatment.

In 2019, approximately 19,000 hip prostheses and 15,000 knee prostheses surgeries were performed in Sweden. The consequences of a prosthetic infection for the patient include longer care and rehabilitation time, long-term pain, risk of reoperation, and increased mortality. An especially vulnerable group is the elderly, fragile patients, who are more susceptible to getting an infection and are most likely to have a mortal outcome.

SSI after orthopedic implant-related surgery also has economic consequences for the healthcare, with an extra cost of 0.5-1 MSEK/deep infection. Based on these socio-economic and humane reasons, there is a great need to prevent SSI. Another reason is the increasing development of antibiotic resistance, which threatens the possibilities of effectively preventing and treating SSI.

Airborne contamination is considered a very important exogenous source of infection. In a land-mark study from 1982 it was showed that ultraclean air in operating rooms (< 10 bacteria-carrying particles (CFU)/m3) reduced the incidence of deep sepsis by 1/3 after total joint-replacement operations compared with control- operating rooms. In addition, there was a substantial reduction in the mean numbers of bacteria isolated from wounds during operations performed under ultraclean-air conditions compared with those isolated from wounds during operations in the control rooms.

In a previous study, we are addressing the issue of possible relationship between air contamination - measured as colony forming units (CFU)/m3, bacteria present in the wound, and the occurrence of SSI. In the study, the bacteriological findings and the incidence of SSI are evaluated in relation to conventional ventilated operating rooms and conventional ventilated operating rooms with the addition of local clean airflow over the surgical instruments. Because particles in the air act as means of transportation for bacteria, there is a consensus that the risk of bacterial airborne infection can be prevented by keeping particle levels as low as possible in the operating room. The most obvious way of controlling the number of particles in the air is via ventilation. The most common types of ventilation in an operating room today is mixed ventilation (also called displaced or conventional ventilation) or vertical laminar airflow (LAF). However, both these systems are very sensitive to disturbances of the airflow caused by e.g. door openings, the number of staff working inside the room and their movements and obstructive objects, as shown in previous studies.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Orthopedic implant related surgery
  • Surgery in operating rooms with installed equipment

排除标准

  • Non-implant related surgery
  • No Swedish citizen (no personal-id number)
  • Revision surgery due to infection

结局指标

主要结局

Environmental parameters association with surgical site infections

时间窗: 01/01/2021 - 12/31/2023

Environmental parameters (temperature, humidity, air pressure, door openings, persons present, particles) are being recorded into a database and cross referenced with patient registries to investigate the association with surgical site infections

Association of bacteria (CFU) and particles

时间窗: 02/28/2022 - 06/31/2023

By measuring particles and CFU in proximity of each other, an association between the two units can be used to predict the CFU, based on the particle count.

次要结局

未报告次要终点

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maziar Mohaddes Ardebili

Professor

Sahlgrenska University Hospital, Sweden

研究点 (1)

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