Development grant for a multicentre, randomised trial to reduce surgical site infection following emergency gastrointestinal surgery in LMICs

问题：肠道手术后伤口感染在所有国家都很常见。它们对病人、医生和卫生系统产生不利影响。对于患者来说，它们是痛苦的，有气味的，降低生活质量，减少恢复正常活动所需的时间。它们很难治疗，需要开长疗程的抗生素处方并返回手术室，增加抗生素耐药性并减少未来可用的治疗。它们非常昂贵，需要长时间的住院和大量的护理时间。在低收入和中等收入国家，这种情况至少是高收入国家的两倍。伤口感染会影响成人和儿童，由于工作年龄的人不能迅速恢复工作，他们的家庭和社区也会受到不利影响。未来拟议的试验：我们的目标是进行一项大型的多国随机对照试验，研究两种简单的干预措施，以减少急诊肠道手术后的伤口感染。急诊手术是低收入和中等收入国家（LMIC）最常见，要求最高和负担最重的肠道手术类型。由于与世界其他地区相比，这些国家的伤口感染负担最高，因此本研究提案及时并专注于LMIC的临床需求。伤口感染是复杂的，同时测试两种干预措施可能比只测试一种更有效，而且它也提高了资金的价值。该试验将是大规模的，需要大约2000名患者。需要开发资助：在我们提交一份极具竞争力的世界级资助申请之前，我们需要进行一些开发工作，以确保我们做好准备。这项工作将为该应用程序制定最终的切实计划，并让当地医生和研究人员参与这一过程。我们的目标是：1.在参与国举行由当地外科医生领导的现场会议，以吸引一系列工作人员和入围干预措施，这些措施可以在其单位进行测试。提供现场研究技能培训，以提高当地的研究能力和领导能力。进行小型观察性研究，以确保研究中心在主要试验期间有随访患者的策略。举行我们的第一次面对面合作者小组会议，根据选定的干预措施制定最终方案，可用于主要试验申请。这次会议也将使我们能够促进我们新的合作和提高团队工作之间的最强可能的关系。需要更多的外科研究：世界各地缺乏外科研究，部分原因是缺乏定期进行外科研究的医生。这一初步建议将允许形成一个可能持续数十年的合作。我们预测，这个网络将使我们能够在未来提供更多的试验，更大的规模和复杂性。在英国，我们已经开发了中心辐射研究网络，以提供类似的试验。我们的目标是将这些研究技能从NHS转移到LMIC，以帮助广泛传播最佳外科研究实践。这也将加快审判人员的招募，并最大限度地提高普遍性。我们的目标是，这一发展赠款和随后的主要赠款将产生一代外科研究人员专注于测试成本效益的干预国际。

THE PROBLEM: Infections in wounds after bowel surgery are common in all countries. They have adverse effects for patients, doctors and health systems. For patients, they are painful, smelly, reduce quality of life and reduce time taken to return to normal activities. They are hard to treat and require prescriptions of long courses of antibiotics and return trips to the operating theatre, increasing antibiotic resistance and reducing future available treatments. They are extremely costly and require long lengths of stay in hospital and lots of nursing time. In low and middle-income countries, they are at least twice as common as they are in high-income countries. Rates of antibiotic resistance are also higher, meaning they are even harder to treat. Wound infections affect both adults and children and since people of working age can't return quickly to work, their families and communities are also adversely affected.FUTURE PROPOSED TRIAL: We aim to perform a large, multi-country randomised controlled trial looking at two simple interventions to reduce wound infections after emergency bowel surgery. Emergency surgery is the most common, demanding and burdensome type of bowel surgery in low and middle income countries (LMICs). Since the burden of wound infections is highest in these countries compared to other places in the world, this research proposal if timely and focussed toward a clinical need in LMICs. Wound infections are complex and testing two interventions at the same time may show even greater effect than just testing one, and it also improves value for money. The trial will be large and require around 2000 patients.NEED FOR A DEVELOPMENT GRANT: Before we can submit a highly competitive, world-class grant proposal, we need to perform some development work to ensure that we are prepared. This work will develop a final, tangible plan for that application, and engage local doctors and research staff into the process. We aim to:1. Hold on site meetings in participating countries, led by local surgeons, to engage a range of staff and shortlist interventions which could be tested in their units.2. Deliver on-site research skills training that will increase local research capacity and leadership.3. Perform small observational studies to ensure that sites have a strategy to follow-up patients during the main trial.4. Hold our first face-to-face collaborator group meeting, to develop a finalised protocol based on the selected interventions, that can be used for a main trial application. This meeting will also allow us to foster the strongest possible relationships between our new collaborative and improve team working.NEED FOR MORE SURGICAL RESEARCH: There is a lack of surgical research across the world, partly driven by a lack of doctors regularly performing surgical research. This initial proposal will allow is to form a collaborative that could last for many decades. We predict that this network will enable us to deliver more trials into the future, of larger sizes and complexity. In the UK, we have developed hub and spoke research networks to deliver similar trials. We aim to transfer these research skills from the NHS to LMICs to help disseminate best surgical research practice widely. This will also speed recruitment to trials and maximise generalizability. We aim that this development grant and subsequent main grant will produce a generation of surgical researchers focused on testing cost-effective interventions internationally.