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.
This report was produced within the framework of the RAAK PRP project ‘Veiligheid op de werkvloer’. Personal protective equipment (PPE) is used on a daily basis by millions of people all over the EU, voluntarily or as a result of EU legislation. In this report we deal specifically with the textile/garment aspects of PPE. In this context we must consider the fact that PPE encompasses a huge area with hundreds of different applications of materials and systems tuned to specific needs;from a materials point of view it represents a complex area due to the large diversity of labour conditions. Textiles and clothing represent an area where PPE is an important area of attention. On a global scale it is an area of much research. Safety and comfort are becoming more and more important and these aspects must be in balance. Uncomfortable systems will not be used and put safe working at risk. Thus there is a continuous need for technological innovation to improve the effectiveness of PPE systems. Specialization and specific combinations aimed at use under well-defined conditions contributes to finding a good balance between comfort and safety. The design of products, taking into account the individual needs represent an area of intensive research: Safety directed ‘fashion design’.The ultimate goal is the development of proactive systems by which workers (but capital goods as well) are optimally protected. There is also a lot of attention for maintenance and cleaning since protective functions may deteriorate as a result of cleaning processes. Another important point is standardization because producers need directions for product development and supply of goods. In our overview we make a distinction between static and dynamic systems. Static systems provide passive protection, simply by being a part of an equipment that separates the worker from the danger zone. Dynamic systems are more ‘intelligent’ because these can react to stimuli and subsequently can take action. These dynamic systems use sensors, communication technology and actuators. From this research the following may be concluded: 1. Safety is obtained by choice of materials for a textile construction, including the use of coatings with special properties, application of specific additives and he use of special designed fibre shapes. 2. The architecture and ultimate construction and the combinations with other materials result in products that respond adequately. This is of great importance because of the balance comfort – safety. But a lot can be improved in this respect. 3. Insight in human behaviour, ambient intelligence and systems technology will lead to new routes for product development and a more active approach and higher levels of safety on the work floor. Consequently there is a lot of research going on that is aimed at improved materials and systems. Also due to the enormous research area of smart textiles a lot of development is aimed at the integration of new technology for application in PPE. This results in complex products that enhance both passive and active safety. Especially the commissioners, government and industry, must pay a lot of attention to specifying the required properties that a product should meet under the specific conditions. This has a cost aspect as well because production volumes are usually not that large if for small groups of products specific demands are defined. We expect that through the technology that is being developed in the scope of mass customization production technologies will be developed that allows production at acceptable cost, but still aimed at products that have specific properties for unique application areas. Purchasing is now being practiced through large procurements. We must than consider the fact that specification takes place on the basis of functionality. In that case we should move away from the current cost focus but the attention should shift towards the life cycle
MULTIFILE
Previous research has shown clinical effectiveness of dermal substitution; however, in burn wounds, only limited effect has been shown. A problem in burn wounds is the reduced take of the autograft, when the substitute and graft are applied in one procedure. Recently, application of topical negative pressure (TNP) was shown to improve graft take. The aim of this study was to investigate if application of a dermal substitute in combination with TNP improves scar quality after burns. In a four-armed multicenter randomized controlled trial, a split-skin graft with or without a dermal substitute and with or without TNP was compared in patients with deep dermal or full-thickness burns requiring skin transplantation. Graft take and rate of wound epithelialization were evaluated. Three and 12 months postoperatively, scar parameters were measured. The results of 86 patients showed that graft take and epithelialization did not reveal significant differences. Significantly fewer wounds in the TNP group showed postoperative contamination, compared to other groups. Highest elasticity was measured in scars treated with the substitute and TNP, which was significantly better compared to scars treated with the substitute alone. Concluding, this randomized controlled trial shows the effectiveness of dermal substitution combined with TNP in burns, based on extensive wound and scar measurements.
