Systematic rewiev, mixed methods best-evidence synthesis and prospective feasibility study for effects of spatial separation of septic and aseptic operating rooms on microbial surrogate parameters, clinical endpoints and process indicators

Status:

completed 03/2020

Aims:

The objective of this research project was to investigate the effects of a spatial separation of septic and aseptic operating rooms on microbial surrogate parameters, clinical endpoints and process indicators. The best available evidence using a systematic review should be aggregated to answer the research question whether spatial separation of septic and aseptic operating theatres has influence on process and/or outcome quality. A prospective trial should provide data on the typical range of interventions and usage of a designated septic operating room, its prevailing microbial ecology, the influence on the rate of nosocomial infections and various process indicators.

Activities/Methods:

Prior to the beginning of the systematic review, a study protocol was registered in PROSPERO (International Prospective Register of Systematic Reviews) under ID CRD42018086568. Literature search was carried out in the electronic bibliographic databases PubMed MEDLINE, Ovid Embase, CINAHL and Cochrane library using a prospectively defined search algorithm. Articles identified using a predefined search algorithm were archived using bibliographic software (EndNote V7.7, Thomson Reuters) and checked for their inclusion criteria independently by two reviewers. Critical risk of bias was assessed according to ROBINS-I. Extensive conceptual work was conducted to plan the prospective trial. An initially planned microbiological analysis turned out to be impractical in a feasibility assessment, which is why the focus was placed on an analysis of the process data in the further process. Therefore, a study protocol and a data protection concept were designed, documentation parameters were implemented in our clinical information system (medico), the study was registered in the German Clinical Trials Register (DRKS) and an ethics application was drawn up resulting in a positive vote. Another adaptation of the concept included an assessment of the process quality in evaluating hand hygiene compliance in the operating room and recordings of the operation room traffic.

Results:

The systematic review was successfully published in the BioMed Central Open Access journal Systematic Reviews. In the literature search, a total of 572 articles initially met the search criteria, of which only one publication provided evidence on the research topic after reviewing the pre-defined selection criteria. However, the identified trial showed a critical risk of bias. The systematic literature analysis therefore did not provide any quantitative information that would allow to draw reliable conclusions about the benefits or possible risks of an architectural separation of septic and aseptic operating units. The prospective trial, which should evaluate the potential benefit of a structural separation, could not be carried out in the BG Klinikum Unfallkrankenhaus Berlin. Due to the extensive and ongoing renovation of the operating rooms, the effort to implement the proposed measures was too high in relation to the scientific significance of surrogate parameters and was not compatible with the obligation of care.

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