Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysisResearch in context
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 interna...
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Published in: | EClinicalMedicine Vol. 62; p. 102105 |
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Elsevier
01-08-2023
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Abstract | 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, I2 = 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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AbstractList | 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, I2 = 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. |
Author | Hasti Jalalzadeh Hannah Groenen Maarten J. van der Laan Ricardo G. Orsini Niels Wolfhagen Roald R. Schaad Yasmine E.M. Dreissen Dennis R. Buis Anne M. Eskes Frank F.A. IJpma Mitchel Griekspoor Wil C. van der Zwet Wouter J. Harmsen Stijn W. de Jonge Marja A. Boermeester Patrique Segers Jon H.M. Goosen |
Author_xml | – sequence: 1 fullname: Hannah Groenen organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands; Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands – sequence: 2 fullname: Hasti Jalalzadeh organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands; Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands – sequence: 3 fullname: Dennis R. Buis organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands – sequence: 4 fullname: Yasmine E.M. Dreissen organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands – sequence: 5 fullname: Jon H.M. Goosen organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Orthopedic Surgery, Sint Maartenskliniek, Ubbergen, Netherlands – sequence: 6 fullname: Mitchel Griekspoor organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Dutch Association of Medical Specialists, Utrecht, Netherlands – sequence: 7 fullname: Wouter J. Harmsen organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Dutch Association of Medical Specialists, Utrecht, Netherlands – sequence: 8 fullname: Frank F.A. IJpma organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Division of Trauma Surgery, Department of Surgery, University Medical Center Groningen, Groningen, Netherlands – sequence: 9 fullname: Maarten J. van der Laan organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, Netherlands – sequence: 10 fullname: Roald R. Schaad organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Anesthesiology, Leiden University Medical Centre, Leiden, Netherlands; Dutch Association of Anesthesiology (NVA), Netherlands – sequence: 11 fullname: Patrique Segers organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Cardiothoracic Surgery, Maastricht University Medical Center+, Maastricht, Netherlands – sequence: 12 fullname: Wil C. van der Zwet organization: Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Department of Medical Microbiology, Infectious Diseases and Infection Prevention, Maastricht University Medical Center, Maastricht, Netherlands – sequence: 13 fullname: Stijn W. de Jonge organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands – sequence: 14 fullname: Ricardo G. Orsini organization: Department of Surgery, Maastricht University Medical Center+, Maastricht, Netherlands – sequence: 15 fullname: Anne M. Eskes organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, Netherlands; Menzies Health Institute Queensland and School of Nursing and Midwifery, Griffith University, Gold Coast, Australia – sequence: 16 fullname: Niels Wolfhagen organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands; Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands – sequence: 17 fullname: Marja A. Boermeester organization: Department of Surgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, Netherlands; Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Netherlands; Corresponding author. Department of Surgery, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands |
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Title | Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysisResearch in context |
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