PDF(Pubmed)
Abstract：
BACKGROUND: The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different.
METHODS: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up.
CONCLUSIONS: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures.
BACKGROUND: Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.
METHODS: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up.
CONCLUSIONS: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures.
BACKGROUND: Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.
摘要：
背景：由于最近道路交通事故的增加，胫骨开放性骨折的发生率在全球范围内迅速增加，主要在低收入和中低收入国家。尽管使用了全身性抗生素和手术清创术，但这些损伤是骨科紧急情况，感染率高达40％。由于增加了局部组织的可用性，局部抗生素的使用在减轻这些损伤中的感染负担方面显示出一些希望；但是，目前还没有一项试验具有适当的能力来评估明确的证据,目前的大多数研究都是在资源和生物负担可能不同的高资源国家进行的.
方法：这是一个前瞻性随机，蒙面,安慰剂对照优势试验旨在评估局部给药庆大霉素与安慰剂在预防主要可封闭Gustillo-AndersonI级成人（年龄>18岁）骨折相关感染中的疗效。II,和IIIA开放性胫骨骨折。八百九十名患者将被随机分配在其主要闭合性开放性骨折部位注射庆大霉素（治疗组）或生理盐水（对照组）。主要结果是在12个月的随访过程中发生骨折相关感染。
结论：本研究将明确评估局部庆大霉素预防坦桑尼亚成人胫骨开放性骨折相关感染的有效性。这项研究的结果有可能证明低成本，广泛可用的干预措施可减少胫骨开放性骨折的感染。
背景：Clinicaltrials.govNCT05157126。2021年12月14日注册。
方法：这是一个前瞻性随机，蒙面,安慰剂对照优势试验旨在评估局部给药庆大霉素与安慰剂在预防主要可封闭Gustillo-AndersonI级成人（年龄>18岁）骨折相关感染中的疗效。II,和IIIA开放性胫骨骨折。八百九十名患者将被随机分配在其主要闭合性开放性骨折部位注射庆大霉素（治疗组）或生理盐水（对照组）。主要结果是在12个月的随访过程中发生骨折相关感染。
结论：本研究将明确评估局部庆大霉素预防坦桑尼亚成人胫骨开放性骨折相关感染的有效性。这项研究的结果有可能证明低成本，广泛可用的干预措施可减少胫骨开放性骨折的感染。
背景：Clinicaltrials.govNCT05157126。2021年12月14日注册。
