Optimal usage of antibacterial sutures for wound closure in clinical trials addressing SSI

We thank Niels-Derrek Schmitz and colleagues for their letter about the FALCON trial.1NIHR Global Research Health Unit on Global SurgeryReducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial.Lancet. 2021; 398: 1687-1699Summary Full Text Full Text PDF PubMed Google Scholar In keeping with our hypothesis, we did not test triclosan-coated sutures for skin closure but we did test them for closure of the deep abdominal wall fascia. The deep fascia is where our network identified clinical equipoise and the highest likelihood of a clinically meaningful effect. Since we are unable to comment on the effectiveness of triclosan-coated skin sutures (which are a different product to that used to close the fascia), these could influence minor superficial infections, warranting further investigation. We combined the definitions of deep and superficial surgical site infections (SSIs) of the abdominal wall in the FALCON trial for two reasons. First, the difference between deep and superficial infections is subjective and differentiating these is unlikely to be reliable in widespread clinical practice. Second, there is likely to be substantial overlap between deep and superficial infections, making it practically hard to separate them as entities in real-world practice. This overlap between deep and superficial infections contrasts with organ space infections, which are clearly separate and which we did not include, as there is no biological rationale. We did not collect data that would permit the suggested secondary analysis of superficial versus deep infections since we concentrated on our prespecified, protocolised primary hypothesis and focused data collection towards that, for more efficient front-line delivery of the trial. Our analysis of reoperation rates (a treatment for some deep SSIs), however, did not show any difference between coated and non-coated sutures. The authors also comment on our meta-analysis in The Lancet Infectious Diseases.2National Institute of Health Research Unit on Global SurgeryAlcoholic chlorhexidine skin preparation or triclosan-coated sutures to reduce surgical site infection: a systematic review and meta-analysis of high-quality randomised controlled trials.Lancet Infect Dis. 2022; 22: 1242-1251Summary Full Text Full Text PDF PubMed Google Scholar Like all meta-analyses, this meta-analysis was designed to inform debate in clinical practice and policy by applying evidence-based medicine. It does suggest that the profound benefits seen for both interventions tested in the FALCON trial (skin preparation and coated sutures) might be explained by high levels of bias. Further secondary analysis of FALCON trial data could identify subgroups where a signal of effect justifies further evaluation. Such analysis needs to be pre-planned and executed to a high methodological standard. We would be delighted to collaborate with the authors to achieve this, which is currently beyond the scope of this response. We declare no competing interests. Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trialThis trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone–iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use. Full-Text PDF Open AccessOptimal usage of antibacterial sutures for wound closure in clinical trials addressing SSIThe FALCON trial1 was a large-scale evaluation of two evidence-based interventions for the prevention of surgical site infection (SSI) in clean-contaminated, or contaminated or dirty abdominal surgical wounds. These interventions were alcoholic chlorhexidine skin preparation and triclosan-coated sutures. Full-Text PDF