Department of General, Visceral and Transplantation Surgery and Study Center of the German Surgical Society (SDGC), University of Heidelberg; Division for Hospital Hygiene, Vienna General Hospital, Medical University Vienna; Institute for Hygiene and Environmental Medicine, University of Greifswald; Institute of Hospital Hygiene und Infection Prevention, Klinikum Konstanz; Institute for Community Medicine, University of Greifswald; Clinic and Outpatient Clinic for Surgery-Department of General Surgery, Visceral, Thoracic and Vascular Surgery, University of Greifswald.
Dtsch Arztebl Int. 2017 Jul 10;114(27-28):465-475. doi: 10.3238/arztebl.2017.0465.
Highly effective measures to prevent surgical wound infections have been established over the last two decades. We studied whether the strict separation of septic and aseptic procedure rooms is still necessary.
In an exploratory, prospective observational study, the microbial concentration in an operating room without a room ventilating system (RVS) was analyzed during 16 septic and 14 aseptic operations with the aid of an air sampler (50 cm and 1 m from the operative field) and sedimentation plates (1 m from the operative field, and contact culture on the walls). The means and standard deviations of the microbial loads were compared with the aid of GEE models (generalized estimation equations).
In the comparison of septic and aseptic operations, no relevant differences were found with respect to the overall microbial concentration in the room air (401.7 ± 176.3 versus 388.2 ± 178.3 CFU/m; p = 0.692 [CFU, colony-forming units]) or sedimentation 1 m from the operative field (45.3 ± 22.0 versus 48.7 ± 18.5 CFU/m/min; p = 0.603) and on the walls (35.7 ± 43.7 versus 29.0 ± 49.4 CFU/m/min; p = 0.685). The only relevant differences between the microbial spectra associated with the two types of procedure were a small amount of sedimentation of and in septic operations, and of and in aseptic operations, up to 30 minutes after the end of the procedure.
These data do not suggest that septic and aseptic procedure rooms need to be separated. In interpreting the findings, one should recall that the study was not planned as an equivalence or non-inferiority study. Wherever patient safety is concerned, high-level safety concepts should only be demoted to lower levels if new and convincing evidence becomes available.
在过去的二十年中,已经建立了预防手术部位感染的高效措施。我们研究了严格区分感染手术间和无菌手术间是否仍然必要。
采用探索性、前瞻性观察研究方法,使用空气采样器(距手术区 50cm 和 1m 处)和沉降平板(距手术区 1m 处,以及在墙上进行接触培养),分析一间无房间通风系统(RVS)的手术室在 16 例感染手术和 14 例无菌手术期间的微生物浓度。使用广义估计方程(GEE)模型比较微生物负荷的平均值和标准差。
在感染手术和无菌手术的比较中,无论是在房间空气中的总体微生物浓度(401.7±176.3 与 388.2±178.3 CFU/m;p=0.692 [CFU,菌落形成单位])还是沉降平板 1m 处(45.3±22.0 与 48.7±18.5 CFU/m/min;p=0.603)以及墙上(35.7±43.7 与 29.0±49.4 CFU/m/min;p=0.685),均未发现有统计学差异。两种手术类型相关的微生物谱之间唯一相关的差异是,在手术结束后 30 分钟内,沉降平板上的 和 沉降量略有增加,而无菌手术中则是 和 的沉降量略有增加。
这些数据表明,感染手术间和无菌手术间不需要分开。在解释这些发现时,应注意到该研究并非作为等效性或非劣效性研究设计的。只要涉及到患者安全,只有在获得新的、令人信服的证据时,才应将高级别的安全概念降级为较低级别。