BackgroundArchitectural division of aseptic and septic operating theatres is a distinct structural feature of surgical departments in Germany. Internationally, hygienists and microbiologists mainly recommend functional separation (i.e. aseptic procedures first) without calling for separate operating floors and rooms. However, patients with severe musculoskeletal infections (e.g. joint empyema, spondylodiscitis, deep implant-associated infections) may benefit from the permanent availability of septic operating capacities without delay caused by an ongoing aseptic surgical program. A systematic literature review on the influence of a structural separation of septic and aseptic operating theatres on process and/or outcome quality has not yet been conducted.MethodsSystematic literature search in PubMed MEDLINE, Ovid Embase, CINAHL and the Cochrane Library, screening of referenced citations, and assessment of grey literature.ResultsA total of 572 articles were found through the systematic literature search. No head-to-head studies (neither randomised, quasi-randomised nor observational) were identified which examined the impact of structural separation of septic and aseptic operating theatres on process and/or outcome quality.ConclusionsThis review did not identify evidence in favour nor against architectural separation of septic or aseptic operating theatre. Specifically, there is no evidence of a harmful effect of architectural separation. Unless prospective studies, ideally randomised trials, will be available, it is unjustified to call for abolishing established hospital structures. Future investigations must address patient-centered endpoints, surgical site infections, process quality and hospital economy.Systematic review registrationPROSPERO (International prospective register of systematic reviews): CRD42018086568.Electronic supplementary materialThe online version of this article (10.1186/s13643-018-0937-9) contains supplementary material, which is available to authorized users.

BackgroundIdiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications.Methods/designIn this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters.DiscussionSYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2951-6) contains supplementary material, which is available to authorized users.