Local antibiotics

局部抗生素
  • 文章类型: Journal Article
    背景:改善局部抗生素递送是改善感染控制并可能缩短假体周围感染(PJI)的全身治疗的一种有前途的方法。这项研究调查了负载抗生素的使用,可塑胶原-磷酸三钙复合材料治疗髋关节PJI。
    方法:纳入转诊中心79例患者的124例应用病例;全身性不良感染,局部并发症,和感染控制进行了分析。
    结果:在大多数情况下,使用万古霉素或美罗培南。先前在20(25%)患者中发现了82(66%)例微生物感染的病原体。没有高钙血症病例。14例(11%)出现急性肾损伤。慢性肾衰竭持续2例。在平均12个月(SD9.3;范围3-35个月)的随访期间,73例(92%)患者获得植入物存活;19例患者因PJI进行了翻修。
    结论:可模制的胶原-磷酸三钙复合骨替代物作为人工髋关节翻修术中的局部抗生素载体,似乎是一种有效的局部抗生素给药选择,没有全身并发症。92%的植入物存活率支持以下假设:局部抗生素治疗是PJI治疗的重要组成部分。
    BACKGROUND: Improving local antibiotic delivery is a promising approach to improve infection control and potentially shorten systemic treatment in periprosthetic joint infection (PJI). This study investigates the use of an antibiotic-loaded, mouldable collagen-tricalciumphosphate composite in treatment of hip PJI.
    METHODS: 124 application cases in 79 patients were included from a referral centre; systemic adverse infects, local complications, and infection control were analysed.
    RESULTS: In most cases, either vancomycin or meropenem were used. Pathogens were previously known in 82 (66%) cases with polymicrobial infection in 20 (25%) patients. There were no cases of hypercalcaemia. Acute kidney injure was present in 14 (11%) cases. Chronic kidney failure persisted in two cases. During a mean follow-up of 12 (SD 9.3; range 3-35) months, implant survival was achieved in 73 (92%) patients; revision due to PJI was performed in 19 cases.
    CONCLUSIONS: Mouldable collagen-tricalciumphosphate composite bone substitute as a local antibiotic carrier in revision hip arthroplasty appears to be a valid option for local antibiotic delivery without systemic complications. Implant survival of 92% supports the hypothesis that local antibiotic therapy is an important component in the treatment of PJI.
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  • 文章类型: Journal Article
    为了改善非手术机械牙周治疗的临床和微生物学结果,辅助使用抗微生物剂已用于治疗中度至重度牙周炎。在我们的研究中,回顾性设计包括以前收集的健康相关患者数据,从接受全身或局部抗生素辅助治疗SI(龈下器械)的患者的印刷和数字图表中获得。共有34例患者(诊断为广泛性III/IV期牙周炎)符合纳入和排除标准,并进行了评估。对样品进行了以下细菌菌株的测试:放线菌聚集杆菌(A.放线菌),牙龈卟啉单胞菌(P.牙龈),介体间普雷沃氏菌(P.intermedia),连翘(T.连翘),和Denticola密螺旋体(T.denticola).细菌种类的组间比较未显示组间的统计学显著差异。本研究旨在评估SI后的临床效果和全身给药(SA)AMX(阿莫西林)+MET(甲硝唑)(给药7天)的辅助使用,在牙周治疗的第2步中使用局部递送(LDD)哌拉西林他唑巴坦。结果:总体而言,所有参数在组中都得到了改善,关于全口出血评分(FMBS)的组间比较有显着差异(p<0.05),有利于SA组,并且p值<0.05被认为具有统计学意义。在3个月的随访中,两组均观察到统计学上显着的PPD(探查袋深度)减少和CAL(临床依恋水平)增加。总之,在限制范围内,这项研究的结果表明,SI,辅助局部或全身抗生素治疗,提供了可比的临床改善。全身性AMX+MET方案在减少FMBS方面更有效。需要更多患者的后续研究来进一步研究这种影响。
    To improve the clinical and microbiological outcomes of non-surgical mechanical periodontal therapy, the adjunctive use of antimicrobials has been utilized in treating moderate-to-severe periodontitis. In our study, the retrospective design included previously collected health-related patient data, obtained from the printed and digital charts of patients who received systemic or local antibiotic adjuncts to SI (subgingival instrumentation). A total of 34 patients (diagnosed with generalized Stage III/IV periodontitis) met the inclusion and exclusion criteria and were evaluated. The samples were tested for the following bacterial strains: Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Porphyromonas gingivalis (P. gingivalis), Prevotella intermedia (P. intermedia), Tanererella forsythia (T. forsythia), and Treponema denticola (T. denticola). The inter-group comparisons of the bacterial species did not show statistically significant differences between groups. The present study aimed to evaluate the clinical effects after SI and the adjunctive use of systemically administered (SA) AMX (amoxicillin) + MET (metronidazole) (administered for 7 days), with locally delivered (LDD) piperacillin + tazobactam in step 2 of periodontal therapy. Results: Overall, all parameters were improved in the groups, with a significant difference in inter-group comparison regarding the full-mouth bleeding score (FMBS) (p < 0.05) in favor of the SA group, and the p-value < 0.05 was considered to be statistically significant. Statistically significant PPD (probing pocket depth) reductions and CAL (clinical attachment level) gains were observed in both groups at the 3-month follow-up. In conclusion, within the limitations, the outcomes of this study suggest that SI, with adjunctive local or systemic antibiotic therapy, provided comparable clinical improvements. Systemic AMX + MET protocols were more efficacious with regard to the reduction in FMBS. Follow-up studies with larger patient numbers are needed to further investigate this effect.
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  • 文章类型: Journal Article
    本研究调查了针部位感染(PSI)的病例,尽管拔除了针,但仍需要手术治疗持续性骨髓炎(OM)。
    本回顾性队列研究包括2011年至2021年PSI后需要进行OM手术的患者。在一个机构中根据方案进行单阶段手术。这涉及深度采样,清创术,植入局部抗生素,培养特异性全身抗生素和软组织闭合。成功的结果定义为手术后至少24个月的无感染间隔。
    确定了27名患者(这些部位是22个胫骨,2humeri,2calcanei,1半径);其中约85%为男性,中位年龄为53.9岁。大多数感染(21/27)发生在骨折治疗之后。15例患者被分类为无并发症的BACH,12例为BACH复合物。葡萄球菌是最常见的病原体,在5例(19%)中检测到多微生物感染。七名患者需要在同一手术中进行的皮瓣覆盖。经过3.99年(2.00-8.05)的中位随访,所有患者在前OM部位保持无感染。局部抗生素治疗后的伤口渗漏在3/27(11.1%)病例中可见,但不需要进一步治疗。
    PSI后骨髓炎并不常见,但对患者有重大影响,因为7例患者需要皮瓣覆盖。这加强了仔细放置销和销部位护理以防止深部感染的需要。这些感染根据方案进行治疗,而不是简单地通过刮宫进行治疗。以这种方式治疗的所有患者在最少2年的随访后保持无感染,表明该方案是有效的。
    销部位感染是外固定中非常常见的并发症。慢性pin位点OM的后遗症很少见,但对患者的影响是巨大的。在这个系列中,超过四分之一的患者需要覆盖皮瓣作为深部感染治疗的一部分.
    弗兰克·FA,PomeroyE,HotchenAJ,etal.销部位感染引起的严重骨髓炎治疗后的临床结果。创伤肢体重建策略2024;19(1):21-25。
    UNASSIGNED: This study has investigated cases of pin site infection (PSI) which required surgery for persistent osteomyelitis (OM) despite pin removal.
    UNASSIGNED: Patients requiring surgery for OM after PSI between 2011 and 2021 were included in this retrospective cohort study. Single-stage surgery was performed in accordance with a protocol at one institution. This involved deep sampling, debridement, implantation of local antibiotics, culture-specific systemic antibiotics and soft tissue closure. A successful outcome was defined as an infection-free interval of at least 24 months following surgery.
    UNASSIGNED: Twenty-seven patients were identified (the sites were 22 tibias, 2 humeri, 2 calcanei, 1 radius); about 85% of them were males with a median age of 53.9 years. The majority of infections (21/27) followed fracture treatment. Fifteen patients were classified as BACH uncomplicated and 12 were BACH complex. Staphylococci were the most common pathogens, polymicrobial infections were detected in five cases (19%). Seven patients required flap coverage which was performed in the same operation.After a median of 3.99 years (2.00-8.05) follow-up, all patients remained infection free at the site of the former OM. Wound leakage after local antibiotic treatment was seen in 3/27 (11.1%) cases but did not require further treatment.
    UNASSIGNED: Osteomyelitis after PSI is uncommon but has major implications for the patient as 7 patients needed flap coverage. This reinforces the need for careful pin placement and pin site care to prevent deep infection. These infections were treated in accordance with a protocol and were not managed simply by curettage. All patients treated in this manner remained infection-free after a minimum follow-up of 2 years suggesting that this protocol is effective.
    UNASSIGNED: Pin site infection is a very common complication in external fixation. The sequela of a chronic pin site OM is rare but the implications to the patient are huge. In this series, more than a quarter of patients required flap coverage as part of the treatment of the deep infection.
    UNASSIGNED: Frank FA, Pomeroy E, Hotchen AJ, et al. Clinical Outcome following Management of Severe Osteomyelitis due to Pin Site Infection. Strategies Trauma Limb Reconstr 2024;19(1):21-25.
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  • 文章类型: Journal Article
    背景:局部递送的抗生素是用于选择性去除或抑制病原微生物的辅助疗法,与牙垢和牙根平整(SRP)联合用于治疗牙周炎。
    目的:本研究的主要目的是评估四环素纤维在与SRP联合用于治疗牙周炎的局部药物递送时对抗米诺环素凝胶的有效性。
    方法:这是一个试验随机开放单,比较三种治疗方式的盲法试验研究:SRP与局部四环素纤维(SRP+T),SRP与外用盐酸米诺环素2%凝胶(SRP+M),和SRP仅作为对照组。探测袋深度(PPD),临床附着丧失(CAL),基线时记录探查出血(BOP)百分比,一个月,三个月后.使用IBM公司对数据进行分析2019年发布。IBMSPSSStatisticsforWindows,版本26.0。Armonk,纽约:IBM公司重复测量ANOVA用于比较三个治疗组之间的临床结果,考虑基线的重复测量,一个月,还有三个月.在95%置信区间小于0.05的p值被认为是统计学显著的。
    结果:组内所有临床参数均有统计学意义的变化,包括口袋深度,临床附着丧失,在探测分数上流血,在不同的时间间隔,1个月后四环素组的平均口袋深度变化最大(平均变化=1.4mm,P<0.001)和超过三个月(平均变化=1.79mm,p<0.001)。对于临床附着丧失,一个月后,临床水平的改善最高见于米诺环素组(平均变化=0.7mm,p<0.05),对照组总体改善(平均变化=1.1mm,p<0.05)。二甲胺四环素组在探查时显示出更大的平均出血变化百分比,一个月后变化最大(平均变化=19.34%,p<0.001)和三个月以上(平均变化=26.42%,p<0.001)。然而,组间无显著差异。
    结论:局部递送四环素和米诺环素凝胶作为SRP的辅助药物是有效的,并且可以改善牙周炎治疗的愈合效果。
    BACKGROUND: Locally delivered antibiotics are adjunctive therapies for the selective removal or inhibition of pathogenic microbes in combination with scaling and root planing (SRP) for the management of periodontitis.
    OBJECTIVE: The primary objective of this study was to evaluate the effectiveness of tetracycline fibers against minocycline gel when used as local drug delivery in conjunction with SRP for treating periodontitis.
    METHODS: This is a pilot randomized open single, blinded trial study comparing three treatment modalities: SRP with topical tetracycline fibers (SRP+T), SRP with topical minocycline HCL 2% gel (SRP+M), and SRP only as a control group. Probing pocket depth (PPD), clinical attachment loss (CAL), and bleeding on probing (BOP) percentages were recorded at baseline, one month, and at the end of three months. The data were subjected to analysis using IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp. Repeated measures ANOVA was used to compare the clinical outcomes between the three treatment groups, accounting for the repeated measurements at baseline, one month, and three months. A p-value less than 0.05 at a 95% confidence interval was deemed statistically significant.
    RESULTS: There were statistically significant changes within the groups in all the clinical parameters, including pocket depth, clinical attachment loss, and bleeding on probing score, at different time intervals, with the greatest mean pocket depth changes seen in the tetracycline group after one month (mean changes = 1.4 mm, P < 0.001) and over three months (mean changes = 1.79 mm, p < 0.001). For clinical attachment loss, after one month, the highest improvement in clinical level was seen in the minocycline group (mean changes = 0.7mm, p < 0.05), and the overall improvement was seen in the control group (mean changes = 1.1mm, p < 0.05). The minocycline group showed greater mean changes in bleeding on probing percentage, with the greatest changes after one month (mean changes = 19.34%, p < 0.001) and over three months (mean changes = 26.42%, p <0.001). However, there was no significant difference between the groups.
    CONCLUSIONS: Locally delivered tetracycline and minocycline gel are effective as adjuncts to SRP and may improve the healing outcome in the management of periodontitis.
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  • 文章类型: Journal Article
    目的:这是随机的,安慰剂对照,双盲临床试验旨在评估专业机械去除斑块(PMPR)联合或不联合哌拉西林联合他唑巴坦凝胶治疗种植体周围黏膜炎(PiM)长达6个月的临床和微生物学疗效.
    方法:该研究纳入了31例种植体周围黏膜炎(探查出血(BoP)>1例患者,与以前的X光片相比,种植体周围没有骨质流失)。在随机分配到测试组和对照组后,患者接受全口龈上洁治术,有或没有哌拉西林加他唑巴坦凝胶.在基线和3个月和6个月后进行临床检查,在基线和3个月后进行微生物学检查.
    结果:六个月后,两种治疗方式均导致植入部位临床参数显著减少和改善.两个研究组都没有完全解决PiM(即,每个植入物的BoP≤1)。在测试组和对照组中,在随后的时间点(p<0.001)之间,具有BoP的植入物的数量在统计学上显著减少。在治疗后6个月(与基线的差异)观察到组间的显著BoP差异(p=0.039)。
    结论:在本研究的局限性内,单次使用缓慢释放,哌拉西林和他唑巴坦凝胶的局部应用抗生素组合,辅助PMPR,显示诊断为PiM的植入物的临床变量有所改善。与对照相比,辅助治疗导致更高的BoP降低,但是在其他临床和微生物学参数的变化方面没有观察到显着差异。
    OBJECTIVE: This randomized, placebo-controlled, double-masked clinical trial aimed to evaluate the clinical and microbiological efficacy of professional mechanical plaque removal (PMPR) with or without adjunctive application of piperacillin plus tazobactam gel in the treatment of peri-implant mucositis (PiM) for up to 6 months.
    METHODS: The study included 31 patients with peri-implant mucositis (bleeding on probing (BoP) > 1 at at least one site at baseline, absence of peri-implant bone loss compared with a previous radiograph). After randomized assignment to test and control groups, patients received full-mouth supragingival scaling with or without piperacillin plus tazobactam gel. Clinical examination was performed at baseline and after 3 and 6 months, and a microbiological examination was performed at baseline and after 3 months.
    RESULTS: After six months, both treatment modalities resulted in significant reductions and improvements in clinical parameters at the implant sites. Neither study group achieved a complete resolution of PiM (i.e., BoP ≤ 1 per implant). The number of implants with BoP decreased statistically significantly between subsequent time points (p < 0.001) in both the test and the control group. Significant BoP differences (p = 0.039) were observed between groups at 6 months (difference to baseline) following therapy.
    CONCLUSIONS: Within the limitations of the present study, the single use of a slow-release, locally applied antibiotic combination of piperacillin and tazobactam gel, adjunctive to PMPR, showed an improvement in clinical variable of implants diagnosed with PiM. The adjunctive treatment resulted in higher BoP reduction when compared to the control, but no significant differences were observed regarding the changes in other clinical and microbiological parameters.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    假体周围关节感染(PJI)是骨科手术中最难治疗的并发症之一。清创术,抗生素,植入物固位(DAIR)代表了急性PJI的有效策略,特别是当使用可吸收的局部抗生素载体和涂层时。这项初步研究的目的是评估在DAIR程序中使用负载抗生素的水凝胶(ALH)和硫酸钙(CS)珠之间的差异。我们分析了自2018年以来接受急性PJI治疗的16例患者,即8例膝关节PJI患者(50%),7名髋部PJI患者(43.7%),和一个与肩膀PJI(6.2%)。9名患者接受了清创术治疗,植入物的抗生素涂层和保留(DACRI)方法,虽然有7人接受了清创术治疗,抗生素珍珠,植入物的保留(DAPRI)方法。我们发现两组在年龄方面没有显着差异,性别,美国麻醉医师协会风险评分,Charlson合并症指数,本地化,从发病到诊断和发病的天数。此外,在感染控制方面,DACRI和DAPRI组之间没有发现差异(15例患者,93.75%,p=0.36)和最后的C反应蛋白值(p=0.26),平均随访26.1±7.7个月。DACRI组一名膝关节白色念珠菌PJI患者的治疗不成功。总之,DAPRI和DACRI似乎是PJIs安全有效的治疗方法。这些证据将鼓励开发用于急性植入物相关感染的局部载体和涂层的新临床研究。
    Periprosthetic joint infections (PJI) are among the most difficult complications to treat in orthopaedic surgery. Debridement, antibiotics, and implant retention (DAIR) represent an efficient strategy for acute PJI, especially when resorbable local antibiotic carriers and coatings are used. The aim of this pilot study was to evaluate the difference between using antibiotic-loaded hydrogel (ALH) and calcium sulphate (CS) beads in the DAIR procedure. We analysed 16 patients who had been treated since 2018 for acute PJI, namely eight patients with knee PJI (50%), seven with hip PJI (43.7%), and one with shoulder PJI (6.2%). Nine patients were treated with the Debridement, Antibiotic Coating and Retention of the Implant (DACRI) method, while seven were treated with the Debridement, Antibiotic Pearls, Retention of the Implant (DAPRI) method. We found no significant differences between the two groups in terms of age, sex, the American Society of Anesthesiologists risk score, Charlson Comorbidity Index, localisation, days from onset to diagnosis and pathogenesis. Furthermore, no differences were found between the DACRI and DAPRI groups in terms of infection control (15 patients, 93.75% with p = 0.36) and last C-Reactive Protein values (p = 0.26), with a mean follow-up of 26.1 ± 7.7 months. Treatment for one patient affected by knee Candida albicans PJI in the DACRI group was not successful. In conclusion, DAPRI and DACRI appear to be safe and effective treatments for PJIs. This evidence will encourage the development of new clinical research into local carriers and coatings for use in acute implant-associated infections.
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  • 文章类型: Journal Article
    开放性胫骨骨折具有很高的感染风险,可导致严重的发病率。在开放性伤口部位局部施用抗生素是一种潜在的有效预防措施,但是评估氨基糖苷类抗生素的数据有限。这项研究的目的是评估一项临床试验的可行性,以测试局部庆大霉素降低开放性胫骨骨折后骨折相关感染的风险。
    这项研究是一个单中心,飞行员,蒙面,在Muhimbili骨科研究所进行的随机对照试验.在伤口闭合后,参与者在术中随机接受庆大霉素溶液或在骨折部位注射生理盐水溶液。随访在2周完成,6周,3个月,6个月,9个月,术后1年。主要可行性结果是入学率和保留率。主要临床结果是骨折相关感染的发生。
    在接受筛查的199名患者中,100名符合条件的患者成功入选,并在9个月内随机分组(11.1名患者/月)。在基线和随访时记录了>95%的病例的完整数据。6周随访率,3个月,6个月,9个月,一年是70%,68%,69%,61%,80%,分别。不良事件或任何测量的主要和次要结局没有差异。
    这项初步研究是首次评估局部使用庆大霉素治疗胫骨开放性骨折的研究之一。结果表明,在这种情况下,可以进行严格的临床试验,可接受的入学率和随访以解决该主题。
    UNASSIGNED: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.
    UNASSIGNED: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection.
    UNASSIGNED: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes.
    UNASSIGNED: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting.
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  • 文章类型: Journal Article
    背景与大量组织丢失相关的开放性骨折是复杂的,并且在管理方面存在挑战;它们与不良预后相关,例如感染,不愈合或截肢。这项研究旨在评估使用辅助局部抗生素羟基磷灰石生物复合材料治疗Gustilo-AndersonIIIB开放性骨折的结果,并进行长达8年的随访。方法回顾性研究。对81例Gustilo-AndersonIIIB骨折患者进行了“固定和皮瓣”肢体重建,并使用生物复合载体进行了辅助局部抗生素治疗。结果所有患者的平均随访时间,在收集数据的时候,55.8个月。以96%的比例实现了联合,保肢率为96.3%,深部感染率为3.7%。结论使用局部抗生素治疗,结合“固定和皮瓣”方法治疗Gustilo-AndersonIIIB开放性骨折,被发现与非常低的金属制品感染率以及高的愈合和肢体抢救率有关。未来的研究应该包括一些功能和生活质量结果测量,以观察这种方法的有效性。
    Background Open fractures associated with significant tissue loss are complex and present challenges in management; they are associated with poor outcomes such as infection, non-union or amputation. This study aimed to evaluate outcomes of using an adjuvant local antibiotic hydroxyapatite bio-composite in the management of open Gustilo-Anderson IIIB fractures with up to eight years of follow-up. Methods This was a retrospective study. A total of 81 patients with Gustilo-Anderson IIIB fractures treated with \"fix and flap\" limb reconstruction with adjuvant local antibiotic therapy using a bio-composite carrier were reviewed. Results  The mean follow-up time for all the patients, at the time of data collection, was 55.8 months. Union was achieved in 96% with a limb salvage rate of 96.3% and a deep infection rate of 3.7%. Conclusion The use of local antibiotic therapy, together with a combined orthoplastic \"fix and flap\" approach for Gustilo-Anderson IIIB open fractures, was found to be associated with a very low rate of metalwork infection and high union and limb salvage rates. Future studies should include some functional and quality of life outcome measures to see the efficacy of this method.
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  • 文章类型: Randomized Controlled Trial
    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。
    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.
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