Dataset Information

Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial

ABSTRACT: Summary

Background

Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.

Methods

FALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone–iodine and non-coated suture, or (4) 10% aqueous povidone–iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749.

Findings

Between Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone–iodine and non-coated suture, and 1449 to aqueous povidone–iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone–iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82–1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81–1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77–1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87–1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures.

Interpretation

This 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.

Funding

National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

SUBMITTER: NIHR Global Research Health Unit on Global Surgery

PROVIDER: S-EPMC8586736 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionNearly every field of medicine has some form of clinical practice guidelines. However, only within the past 5-10 years has the medical community acknowledged the need for well-developed guidelines tailored to the local healthcare needs and the resources available. In most low-income and middle-income countries (LMICs), healthcare workers depend on guidelines developed in high-income countries (HICs), yet many interventions validated in a HIC are ineffective when implemented in an LMIC. The variation in infrastructure, medical personnel, technology and environmental conditions exhibited in LMICs relative to HICs necessitates a careful appraisal of the evidence base used in clinical guideline recommendations. This review aims to map the use of resource-stratified guidelines across all fields of medicine. The review seeks to answer three questions for the identified guidelines: (1) what was the method of development, (2) have they been implemented and, if so, (3) have they been validated.MethodsThe search strategy will aim to locate studies from inception to November 2021. An initial limited search of PubMed and Scopus was undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the articles were used to develop a full search strategy for PubMed and Scopus. This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. Data to be extracted from each study will include population characteristics of both developers and intended implementation population, medical specialty, validation status, method of guideline development, whether the study is consensus or evidence-based in addition to a summary of recommendations for practice.Ethics and disseminationEthical approval is not required for this review. The plan for dissemination is to publish review findings in a peer-reviewed journal.

Project description:BackgroundAccess to timely and quality surgical care is limited in low- and middle-income countries (LMICs). Telemedicine, defined as the remote provision of health care using information, communication and telecommunication platforms have the potential to address some of the barriers to surgical care. However, synthesis of evidence on telemedicine use in surgical care in LMICs is lacking.AimTo describe the current state of evidence on the use and distribution of telemedicine for surgical care in LMICs.MethodsThis was a scoping review of published and relevant grey literature on telemedicine use for surgical care in LMICs, following the PRISMA extension for scoping reviews guideline. PubMed-Medline, Web of Science, Scopus and African Journals Online databases were searched using a comprehensive search strategy from 1 January 2010 to 28 February 2021.ResultsA total of 178 articles from 53 (38.7%) LMICs across 11 surgical specialties were included. The number of published articles increased from 2 in 2010 to 44 in 2020. The highest number of studies was from the World Health Organization Western Pacific region (n = 73; 41.0%) and of these, most were from China (n = 69; 94.5%). The most common telemedicine platforms used were telephone call (n = 71, 39.9%), video chat (n = 42, 23.6%) and WhatsApp/WeChat (n = 31, 17.4%). Telemedicine was mostly used for post-operative follow-up (n = 71, 39.9%), patient education (n = 32, 18.0%), provider training (n = 28, 15.7%) and provider-provider consultation (n = 16, 9.0%). Less than a third (n = 51, 29.1%) of the studies used a randomised controlled trial design, and only 23 (12.9%) reported effects on clinical outcomes.ConclusionTelemedicine use for surgical care is emerging in LMICs, especially for post-operative visits. Basic platforms such as telephone calls and 2-way texting were successfully used for post-operative follow-up and education. In addition, file sharing and video chatting options were added when a physical assessment was required. Telephone calls and 2-way texting platforms should be leveraged to reduce loss to follow-up of surgical patients in LMICs and their use for pre-operative visits should be further explored. Despite these telemedicine potentials, there remains an uneven adoption across several LMICs. Also, up to two-thirds of the studies were of low-to-moderate quality with only a few focusing on clinical effectiveness. There is a need to further adopt, develop, and validate telemedicine use for surgical care in LMICs, particularly its impact on clinical outcomes.

Project description:BackgroundWorldwide, approximately one in six inpatient antibiotic prescriptions are for surgical-infection prophylaxis, including postoperative prophylaxis. The WHO recommends against prolonged postoperative antibiotics to prevent surgical-site infection. However, in many low- and middle-income countries, postoperative antibiotic prophylaxis is common due to perceptions that it protects against surgical-site infection and data informing recommendations against antibiotic administration are largely derived from high-income countries. The aim of this study was to describe postoperative antibiotic-prescribing patterns and related surgical-site infection rates in hospitals in low- and middle-income countries.MethodsPatients from 19 hospitals in Ethiopia, Madagascar, India, and Bolivia with wound class I and II operations were included. Data on antibiotic administration, indication, surgical-site infection, length of hospital stay, and adherence to perioperative infection-prevention standards were collected by trained personnel. The association between postoperative antibiotic prophylaxis for greater than or equal to 24 h and surgical-site infection was analysed via modified robust Poisson regression, controlling for patient and procedural factors and degree of adherence to perioperative infection-prevention practices.ResultsOf 8714 patients, 92.9% received antibiotics for prophylaxis after surgery and 27.7% received antibiotics for greater than or equal to 24 h. Patients receiving postoperative prophylaxis for greater than or equal to 24 h did not have lower surgical-site infection rates (Relative risk 1.09 (95% c.i. 0.89 to 1.33); P = 0.399), but the length of hospital stay was 1.4 days longer (P < 0.001).ConclusionProlonged postoperative antibiotics did not reduce surgical-site infection, but pervasive use was associated with a longer length of hospital stay, in resource-limited healthcare systems. With the growing threat of antimicrobial resistance, surgical initiatives to implement antimicrobial stewardship programmes in low- and middle-income countries are critical.

Project description:ObjectiveDetermine the sensitivity and specificity of neonatal jaundice visual estimation by primary healthcare workers (PHWs) and physicians as predictors of hyperbilirubinaemia.DesignMulticentre observational cohort study.SettingHospitals in Chandigarh and Delhi, India; Dhaka, Bangladesh; Durban, South Africa; Kumasi, Ghana; La Paz, Bolivia.ParticipantsNeonates aged 1-20 days (n=2642) who presented to hospitals for evaluation of acute illness. Infants referred for any reason from another health facility or those needing immediate cardiopulmonary resuscitation were excluded.Outcome measuresInfants were evaluated for distribution (head, trunk, distal extremities) and degree (mild, moderate, severe) of jaundice by PHWs and physicians. Serum bilirubin level was determined for infants with jaundice, and analyses of sensitivity and specificity of visual estimations of jaundice used bilirubin thresholds of >260 µmol/L (need for phototherapy) and >340 µmol/L (need for emergency intervention in at-risk and preterm babies).Results1241 (47.0%) neonates had jaundice. High sensitivity for detecting neonates with serum bilirubin >340 µmol/L was found for 'any jaundice of the distal extremities (palms or soles) OR deep jaundice of the trunk or head' for both PHWs (89%-100%) and physicians (81%-100%) across study sites; specificity was more variable. 'Any jaundice of the distal extremities' identified by PHWs and physicians had sensitivity of 71%-100% and specificity of 55%-95%, excluding La Paz. For the bilirubin threshold >260 µmol/L, 'any jaundice of the distal extremities OR deep jaundice of the trunk or head' had the highest sensitivity across sites (PHWs: 58%-93%, physicians: 55%-98%).ConclusionsIn settings where serum bilirubin cannot be measured, neonates with any jaundice on the distal extremities should be referred to a hospital for evaluation and management, where delays in serum bilirubin measurement and appropriate treatment are anticipated following referral, the higher sensitivity sign, any jaundice on the distal extremities or deep jaundice of the trunk or head, may be preferred.

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