TCTR20170123002已完成3 期
A multicenter study of localized antibiotic released hydroxyapatite beads for bone infection treatment in Thailand
Health System Research Institute0 个研究点目标入组 53 人开始时间: 2017年1月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
Satisfactory outcomes were observed in term of success rate, quality of life and adverse effect. Systemic exposure to vancomycin and gentamicin after beads implantation was limited and high local antibiotics concentrations were found in wound drainage fluid at 24, 48 and 72 h. Blood chemistry measurements did not show any nephrotoxic or hepatotoxic effects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •Patients who are diagnosed as chronic osteomyelitis by having bone infection for more than 6 weeks, having dead bone and bone reparative reaction.
- •-Cierny & Mader anatomical staging class A and B.
排除标准
- •-Patients who are allergy to vancomycin, gentamicin and fosfomycin antibiotics
- •-Patient who need ongoing antibiotics treatment i.e melioidosis.
- •-Patients who have renal insufficiency or renal failure (eGFR < 30 ml/min/m2 by Cockcroft-Gault equation (CG))
- •-HIV patients and/or CD4 < 350 cell/ mm3
- •-Patients who are pregnant and lactation
- •-DM patients or having HbA1C > 8% at 3 months prior to enrollment.
- •-Patients who have multiple active injuries or head injuries
- •-Immunocompromided patient or having history of using immunosuppressive drug or corticosteroid equivalent to Prednisolone > 10 mg per day for longer than 2 wks
- •-Patients having history of using folk medicine containing steroids
- •-Patients who have malignancy at site of infection
- •-Patients who use or having history of using narcotic drugs or using syringe with others.
- •-Patient who were infected with antibiotic-resistant gram-negative bacteria
研究者
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