BACKGROUND: The evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and ambiguous. Implementation in daily practice is impaired by inconsistent recommendations in current international guidelines and published meta-analyses. More recently, multiple new randomised controlled trials (RCTs) have been published. We aimed to provide an overview of all meta-analyses and their characteristics; to conduct a new and up-to-date systematic review and meta-analysis and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment; and to explore the additive value of new RCTs with a trial sequential analysis (TSA).METHODS: PubMed, Embase and Cochrane CENTRAL databases were searched from database inception to October 24, 2022. We identified existing meta-analyses covering all surgical specialties and RCTs studying the effect of iNPWT compared with standard dressings in all types of surgery on the incidence of SSI, wound dehiscence, reoperation, seroma, hematoma, mortality, readmission rate, skin blistering, skin necrosis, pain, and adverse effects of the intervention. We calculated relative risks (RR) with corresponding 95% confidence intervals (CI) using a Mantel-Haenszel random-effects model. We assessed publication bias with a comparison-adjusted funnel plot. TSA was used to assess the risk of random error. The certainty of evidence was evaluated using the Cochrane Risk of Bias-2 (RoB2) tool and GRADE approach. This study is registered with PROSPERO, CRD42022312995.FINDINGS: We identified eight previously published general meta-analyses investigating iNPWT and compared their results to present meta-analysis. For the updated systematic review, 57 RCTs with 13,744 patients were included in the quantitative analysis for SSI, yielding a RR of 0.67 (95% CI: 0.59-0.76, I 2 = 21%) for iNPWT compared with standard dressing. Certainty of evidence was high. Compared with previous meta-analyses, the RR stabilised, and the confidence interval narrowed. In the TSA, the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate from the meta-analysis. INTERPRETATION: In this up-to-date meta-analysis, GRADE assessment shows high-certainty evidence that iNPWT is effective in reducing SSI, and uncertainty is less than in previous meta-analyses. TSA indicated that further trials are unlikely to change the effect estimate for the outcome SSI; therefore, if future research is to be conducted on iNPWT, it is crucial to consider what the findings will contribute to the existing robust evidence.FUNDING: Dutch Association for Quality Funds Medical Specialists.
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BACKGROUND: Accurate and timely patient handovers from hospital to other health care settings are essential in order to provide high quality of care and to ensure patient safety. We aim to investigate the effect of a comprehensive discharge bundle, the Transfer Intervention Procedure (TIP), on the time between discharge and the time when the medical, medication and nursing handovers are sent to the next health care provider. Our goal is to reduce this time to 24 h after hospital discharge. Secondary outcomes are length of hospital stay and unplanned readmission within 30 days rates.METHODS: The current study is set to implement the TIP, a structured discharge process for all patients admitted to the hospital, with the purpose to provide a safe, reliable and accurate discharge process. Eight hospitals in the Netherlands will implement the TIP on one internal medicine and one surgical ward. An interrupted time series (ITS) analysis, with pre-defined pre and post intervention periods, will be conducted. Patients over the age of 18 admitted for more than 48 h to the participating wards are eligible for inclusion. At least 1000 patients will be included in both the pre-implementation and post-implementation group. The primary outcome is the number of medical, medication and nursing handovers being sent within 24 h after discharge. Secondary outcomes are length of hospital stay and unplanned readmission within 30 days. With regard to potential confounders, data will be collected on patient's characteristics and information regarding the hospitalization. We will use segmented regression methods for analyzing the data, which allows assessing how much TIP changed the outcomes of interest immediately and over time.DISCUSSION: This study protocol describes the implementation of TIP, which provides the foundation for a safe, reliable and accurate discharge process. If effective, nationwide implementation of the discharge bundle may result from this study protocol.TRIAL REGISTRATION: Dutch Trial Registry: NTR5951.
