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 cleancontaminated, 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 (

Aim Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low‐ and middle‐income countries (LMICs) but there is little high‐quality evidence on interventions to prevent SSI in LMICs. Method FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone‐iodine for skin preparation, or (2) triclosan‐coated suture versus non‐coated suture for fascial closure, can reduce surgical site infection at 30‐days post‐surgery for each of (1) clean‐contaminated and (2) contaminated/dirty surgery. Patients with predicted clean‐contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan‐coated suture, (3) 10% aqueous povidone–iodine and noncoated suture and (4) 10% aqueous povidone–iodine and triclosan‐coated suture. The two strata (clean‐contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI. Conclusion FALCON will deliver high‐quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.

ObjectivesMeasures to limit the spread of infection during the COVID-19 global pandemic have made engaging and involving members of the community in global health research more challenging. This research aimed to explore how global health researchers adapted to the imposed pandemic measures in low and middle income countries (LMICs) and how they overcame challenges to effective community engagement and involvement (CEI).DesignA qualitative two-stage mixed-methods study involving an online survey and a virtual round table.SettingThe survey and round table were completed online.ParticipantsOf 53 participants, 43 were LMIC-based or UK-based global health researchers and/or CEI professionals, and 10 worked for the National Institute for Health Research or UK Government’s Department of Health and Social Care.Outcome measuresThis study aimed to capture data on: the number of CEI activities halted and adapted because of the COVID-19 pandemic; where CEI is possible; how it has been adapted; what the challenges and successes were; and the potential impact of adapted or halted CEI on global health research.ResultsPandemic control measures forced the majority of researchers to stop or amend their planned CEI activities. Most face-to-face CEI activities were replaced with remote methods, such as online communication. Virtual engagement enabled researchers to maintain already established relationships with community members, but was less effective when developing new relationships or addressing challenges around the inclusion of marginalised community groups.ConclusionsCOVID-19 has highlighted the need for contingency planning and flexibility in CEI. The redesigning and adopting of remote methods has come with both advantages and disadvantages, and required new skills, access to technology, funding, reliable services and enthusiasm from stakeholders. The methods suggested have the potential to augment or substitute previously preferred CEI activities. The effectiveness and impact of these remote CEI activities need to be assessed.

Background Involving patients and communities with health research in low- and middle-income countries (LMICs) contributes to increasing the likelihood that research is relevant in local context and caters to the needs of the population, including vulnerable and marginalised groups. When done right, it can also support empowerment of wider communities in taking ownership of their own health, lead to increased access and uptake of health services and generally improve the wellbeing of individuals. However, the evidence base of how to undertake successful community engagement and involvement (CEI) activities in LMICs is sparse. This paper aims to add to the available literature and describes how the Global Health Research Unit on Global Surgery’s (GSU) team in Ghana worked collaboratively with the Unit’s team in the UK and a UK-based Public Advisory Group to involve community stakeholders in rural Ghana with surgical research. The aim was to explore ways of reaching out to patients and community leaders in rural Ghana to have conversations that inform the relevance, acceptability, and feasibility of a clinical trial, called TIGER. Methods As this kind of larger scale involvement of community stakeholders with research was a novel way of working for the team in Ghana, a reflective approach was taken to outline step-by-step how the GSU team planned and undertook these involvement activities with 31 hernia patients, two Chiefs (community leaders), a community finance officer and a local politician in various locations in Ghana. The barriers that were experienced and the benefits of involving community stakeholders are highlighted with the aim to add to the evidence base of CEI in LMICs. Results GSU members from the UK and Ghana planned and organised successful involvement activities that focused on establishing the best way to talk to patients and other community stakeholders about their experiences of living with hernias and undergoing hernia repairs, and their perceptions of the impact of hernias on the wider community. The Ghanaian team suggested 1:1 conversations in easily accessible locations for rural patient contributors, creating a welcoming environment and addressing contributors in their local dialects. A UK-based Public Advisory Group helped in the initial stages of planning these conversations by highlighting potential barriers when approaching rural communities and advising on how to phrase questions around personal experiences. Conversations mainly focused on understanding the needs of hernia patients in rural Ghana to then incorporate these in the design of the TIGER trial to ensure its relevance, acceptability and feasibility. When talking to patient contributors, the GSU teams found that they were more likely to open up when they knew members of the team and the opportunity to speak to local leaders only arose because of the Ghanaian team members being well-respected amongst communities. The experiences of the patient and community contributors led to changes in the study protocol, such as including women in the patient cohort for the trial, and allowed the GSU teams to confirm the relevance and acceptability of this trial. These conversations also taught the team a lot about perceptions of health in rural communities, allowed the Ghanaian team to establish relationships with community leaders that can be utilised when future studies need input from the public, and has changed the minds of the Ghanaian research team about the importance of involving patients with research. Conclusion This paper contributes to the evidence base on successful CEI activities in LMICs by providing an example of how CEI can be planned and organised, and the benefits this provides. The conversations the teams had with patient contributors in Ghana are an example of successful patient consultations. Even though there are certain limitations to the extent of these involvement activities, a solid foundation has been built for researchers and community stakeholders to establish relationships for ongoing involvement.