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1.
JAMA Surg ; 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38656408

RESUMO

Importance: Surgical site infections (SSIs) are common postoperative complications and associated with significant morbidity, mortality, and costs. Prophylactic intraoperative incisional wound irrigation is used to reduce the risk of SSIs, and there is great variation in the type of irrigation solutions and their use. Objective: To compare the outcomes of different types of incisional prophylactic intraoperative incisional wound irrigation for the prevention of SSIs in all types of surgery. Data Sources: PubMed, Embase, CENTRAL, and CINAHL databases were searched up to June 12, 2023. Study Selection: Included in this study were randomized clinical trials (RCTs) comparing incisional prophylactic intraoperative incisional wound irrigation with no irrigation or comparing irrigation using different types of solutions, with SSI as a reported outcome. Studies investigating intracavity lavage were excluded. Data Extraction and Synthesis: This systematic review and network meta-analysis is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. Two reviewers independently extracted the data and assessed the risk of bias within individual RCTs using the Cochrane Risk of Bias 2 tool and the certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation framework. A frequentist network meta-analysis was conducted, and relative risks (RRs) with corresponding 95% CIs were reported. Main Outcome and Measure: The primary study outcome was SSI. Results: A total of 1587 articles were identified, of which 41 RCTs were included in the systematic review, with 17 188 patients reporting 1328 SSIs, resulting in an overall incidence of 7.7%. Compared with no irrigation, antiseptic solutions (RR, 0.60; 95% CI, 0.44-0.81; high level of certainty) and antibiotic solutions (RR, 0.46; 95% CI, 0.29-0.73; low level of certainty) were associated with a beneficial reduction in SSIs. Saline irrigation showed no statistically significant difference compared with no irrigation (RR, 0.83; 95% CI, 0.63-1.09; moderate level of certainty). Conclusions and Relevance: This systematic review and network meta-analysis found high-certainty evidence that prophylactic intraoperative incisional wound irrigation with antiseptic solutions was associated with a reduction in SSIs. It is suggested that the use of antibiotic wound irrigation be avoided due to the inferior certainty of evidence for its outcome and global antimicrobial resistance concerns.

2.
EClinicalMedicine ; 62: 102105, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37538540

RESUMO

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.

6.
Lancet Microbe ; 3(10): e762-e771, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35985350

RESUMO

BACKGROUND: Surgical site infection (SSI) is the most common postoperative complication and substantially increases health-care costs. Published meta-analyses and international guidelines differ with regard to which preoperative skin antiseptic solution and concentration has the highest efficacy. We aimed to compare the efficacy of different skin preparation solutions and concentrations for the prevention of SSIs, and to provide an overview of current guidelines. METHODS: This systematic review and network meta-analysis compared different preoperative skin antiseptics in the prevention of SSIs in adult patients undergoing surgery of any wound classification. We searched for randomised controlled trials (RCTs) in MEDLINE, Embase, and Cochrane CENTRAL, published up to Nov 23, 2021, that directly compared two or more antiseptic agents (ie, chlorhexidine, iodine, or olanexidine) or concentrations in aqueous and alcohol-based solutions. We excluded paediatric, animal, and non-randomised studies, and studies not providing standard preoperative intravenous antibiotic prophylaxis. Studies with no SSIs in both groups were excluded from the quantitative analysis. Two reviewers screened and reviewed eligible full texts and extracted data. The primary outcome was the occurrence of SSI (ie, superficial, deep, and organ space). We conducted a frequentist random effects network meta-analysis to estimate the network effects of the skin preparation solutions on the prevention of SSIs. A risk-of-bias and Grading of Recommendations, Assessment, Development, and Evaluation assessment were done to determine the certainty of the evidence. This study is registered with PROSPERO, CRD42021293554. FINDINGS: Overall, 2326 articles were identified, 33 studies were eligible for the systematic review, and 27 studies with 17 735 patients reporting 2144 SSIs (overall incidence of 12·1%) were included in the quantitative analysis. Only 2·0-2·5% chlorhexidine in alcohol (relative risk 0·75, 95% CI 0·61-0·92) and 1·5% olanexidine (0·49, 0·26-0·92) significantly reduced the rate of SSIs compared with aqueous iodine. For clean surgery, we found no difference in efficacy between different concentrations of chlorhexidine in alcohol. Seven RCTs were at high risk of bias, 24 had some concerns, and two had low risk of bias. Heterogeneity across the studies was moderate (I2=27·5%), and netsplitting did not show inconsistencies between direct and indirect comparisons. Five of ten studies that mentioned adverse events related to the skin preparation solutions reported no adverse events, and five reported a total of 56 mild events (mainly erythema, pruritus, dermatitis, skin irritation, or mild allergic symptoms); none reported a substantial difference in adverse events between groups. INTERPRETATION: For adult patients undergoing a surgical procedure of any wound classification, skin preparation using either 2·0-2·5% chlorhexidine in alcohol or 1·5% olanexidine is most effective in the prevention of SSIs. For clean surgery, no specific concentration of chlorhexidine in alcohol can be recommended. The efficacy of olanexidine was established by a single randomised trial and further investigation is needed. FUNDING: Dutch Association for Quality Funds Medical Specialists.


Assuntos
Anti-Infecciosos Locais , Iodo , Anti-Infecciosos Locais/uso terapêutico , Biguanidas , Clorexidina/uso terapêutico , Etanol/uso terapêutico , Abordagem GRADE , Humanos , Incidência , Iodo/uso terapêutico , Metanálise em Rede , Povidona-Iodo/uso terapêutico , Infecção da Ferida Cirúrgica/epidemiologia
7.
Br J Surg ; 109(10): 933-942, 2022 09 09.
Artigo em Inglês | MEDLINE | ID: mdl-35766252

RESUMO

BACKGROUND: Care bundles are used widely to prevent surgical-site infections (SSIs). Recent systematic reviews suggested larger effects from bundles with more interventions. These reviews were largely based on uncontrolled before-after studies and did not consider their biases. The aim of this meta-analysis was to determine the effectiveness of care bundles to prevent SSIs and explore characteristics of effective care bundles. METHODS: A systematic review, reanalysis, and meta-analysis of available evidence were undertaken. RCTs, controlled before-after studies, and uncontrolled before-after studies with sufficient data for reanalysis as interrupted time series studies (ITS) were eligible. Studies investigating the use of a care bundle, with at least one intraoperative intervention, compared with standard care were included. RESULTS: Four RCTs, 1 controlled before-after study, and 13 ITS were included. Pooled data from RCTs were heterogeneous. Meta-analysis of ITS resulted in a level change of -1.16 (95 per cent c.i.-1.78 to -0.53), indicating a reduction in SSI. The effect was larger when the care bundle comprised a higher proportion of evidence-based interventions. Meta-regression analyses did not show statistically significant associations between effect estimates and number of interventions, number of evidence-based interventions, or proportion of evidence-based interventions. CONCLUSION: Meta-analysis of ITS indicated that perioperative care bundles prevent SSI. This effect is inconsistent across RCTs. Larger bundles were not associated with a larger effect, but the effect may be larger if the care bundle contains a high proportion of evidence-based interventions. No strong evidence for characteristics of effective care bundles was identified.


Assuntos
Pacotes de Assistência ao Paciente , Infecção da Ferida Cirúrgica , Humanos , Assistência Perioperatória , Infecção da Ferida Cirúrgica/prevenção & controle
8.
Ann Surg ; 275(6): 1050-1057, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35275885

RESUMO

OBJECTIVE: The aim of this study was to determine the effect of preoperative surgical antibiotic prophylaxis (SAP) with additional intraoperative redosing compared to single-dose preoperative surgical antibiotic prophylaxis on the incidence of surgical site infections (SSI). SUMMARY BACKGROUND DATA: Preoperative SAP is standard care for the prevention of SSI. During long surgical procedures, additional intraoperative redosing of SAP is advised, but there is great variability in redosing strategies and compliance rates. METHODS: We performed a systematic search of MEDLINE (PubMed), Embase, CINAHL and CENTRAL on June 25th, 2021 according to PROSPERO registration CRD42021229035. We included studies that compared the effect of preoperative SAP with additional intraoperative redosing to single dose preoperative SAP (no redosing) on SSI incidence in patients undergoing any type of surgery. Two researchers performed data appraisal and extraction of summary data independently. Meta-analyses were stratified per study type. We used a generic inverse variance random-effects model to estimate a pooled odds ratio with corresponding 95% confidence intervals (CIs). RESULTS: We included 2 randomized controlled trials (RCT) and 8 cohort studies comprising of 9470 patients. Pooled odds ratios for SSI in patients receiving intraoperative redosing compared to those without redosing were 0.47 (95% CI: 0.19-1.16. I2 = 36%) for RCTs and 0.55 (95% CI: 0.38-0.79, I2 = 56%) for observational cohorts. There was considerable clinical heterogeneity among antibiotics used and redosing protocols. GRADE-assessment showed overall low certainty of evidence. CONCLUSION: Intraoperative redosing of SAP may reduce incidence of SSI compared to a single dose preoperative SAP in any type of surgery, based on studies with considerable heterogeneity of antibiotic regimens and redosing protocols.


Assuntos
Antibioticoprofilaxia , Infecção da Ferida Cirúrgica , Antibacterianos/uso terapêutico , Antibioticoprofilaxia/métodos , Estudos de Coortes , Humanos , Incidência , Infecção da Ferida Cirúrgica/tratamento farmacológico , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle
9.
BMJ Open ; 12(2): e054534, 2022 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-35197346

RESUMO

INTRODUCTION: Acute abdominal wound dehiscence (AWD) or burst abdomen is a severe complication after abdominal surgery with an incidence up to 3.8%. Surgical site infection (SSI) is the biggest risk factor for the development of AWD. It is strongly suggested that the use of triclosan-coated sutures (TCS) for wound closure reduces the risk of SSI. We hypothesise that the use of TCS for abdominal wound closure may reduce the risk of AWD. Current randomised controlled trials (RCTs) lack power to investigate this. Therefore, the purpose of this individual participant data meta-analysis is to evaluate the effect of TCS for abdominal wound closure on the incidence of AWD. METHODS AND ANALYSIS: We will conduct a systematic review of Medline, Embase and Cochrane Central Register of Controlled Trials for RCTs investigating the effect of TCS compared with non-coated sutures for abdominal wound closure in adult participants scheduled for open abdominal surgery. Two independent reviewers will assess eligible studies for inclusion and methodological quality. Authors of eligible studies will be invited to collaborate and share individual participant data. The primary outcome will be AWD within 30 days after surgery requiring reoperation. Secondary outcomes include SSI, all-cause reoperations, length of hospital stay and all-cause mortality within 30 days after surgery. Data will be analysed with a one-step approach, followed by a two-step approach. In the one-step approach, treatment effects will be estimated as a risk ratio with corresponding 95% CI in a generalised linear mixed model framework with a log link and binomial distribution assumption. The quality of evidence will be judged using the Grading of Recommendations Assessment Development and Evaluation approach. ETHICS AND DISSEMINATION: The medical ethics committee of the Amsterdam UMC, location AMC in the Netherlands waived the necessity for a formal approval of this study, as this research does not fall under the Medical Research involving Human Subjects Act. Collaborating investigators will deidentify data before sharing. The results will be submitted to a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42019121173.


Assuntos
Traumatismos Abdominais , Técnicas de Fechamento de Ferimentos Abdominais , Triclosan , Abdome/cirurgia , Técnicas de Fechamento de Ferimentos Abdominais/efeitos adversos , Adulto , Humanos , Incidência , Metanálise como Assunto , Deiscência da Ferida Operatória/epidemiologia , Deiscência da Ferida Operatória/prevenção & controle , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Suturas/efeitos adversos , Revisões Sistemáticas como Assunto
10.
Ann Surg Open ; 3(3): e175, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37601145

RESUMO

Objective: To compare the effect of different methods of bowel preparation on the incidence of surgical site infections (SSI), anastomotic leakage (AL), and mortality in patients undergoing elective colorectal surgery. Background: Recent guidelines advise mechanical bowel preparation with oral antibiotics (MBP-OA) for the prevention of SSI in colorectal surgery. Recent trials suggest oral antibiotics (OA) alone may be sufficient. Methods: PubMed, MEDLINE, and Embase were searched from inception until 10-08-2021. We included randomized controlled trials (RCTs) comparing multiple methods of bowel preparation (mechanical bowel preparation [MBP], OA, MBP-OA, or no preparation) with regards to clinical outcomes such as incidence of SSI, AL, and mortality rates. A frequentist random-effects network meta-analysis was conducted to estimate the network effects of the different treatment options. Results: We included 48 studies with 13,611 patients. Compared to no preparation, combined direct and indirect network estimates showed a relative risk (RR) for SSI of 0.57 (95% confidence interval [CI], 0.45-0.72) for MBP-OA, 0.68 (95% CI, 0.49-0.95) for OA, and 1.05 (95% CI, 0.87-1.26) for MBP. The RR for MBP-OA compared to OA was 0.84 (95% CI, 0.60-1.19); in sensitivity analysis of mainly laparoscopic procedures this effect of MBP-OA was more profound (RR, 0.56; 95% CI, 0.31-0.99). Conclusions: This network meta-analysis of RCTs finds that both mechanical bowel preparation with oral antibiotics and oral antibiotics alone are comparably effective in the prevention of SSI. The evidence is uncertain about the relative benefit of MBP-OA compared to OA alone. Therefore, it seems justified to use either of the 2 for the prevention of SSI in colorectal surgery.

12.
BMJ Open ; 10(5): e038196, 2020 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-32457082

RESUMO

INTRODUCTION: Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI. METHODS AND ANALYSIS: EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: Registered in the Dutch Trial Register: NL5572.


Assuntos
Procedimentos Cirúrgicos Eletivos , Infecção da Ferida Cirúrgica , Abdome/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Países Baixos , Assistência Perioperatória , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle
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