ISRCTN10873696进行中（未招募）Unknown
Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: a randomized controlled trial
Vall d'Hebron Institut de Recerca0 个研究点目标入组 50 人开始时间: 2023年12月19日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >18 years old
- •2. Patients with hip or knee prostheses
- •3. Diagnosis of periprosthetic joint infection according to the criteria established in the Second International Consensus on Musculoskeletal Infections
- •4. Acute PJI: <6 weeks since the initial arthroplasty surgery
- •5. Acute hematogenous PJI: <3 weeks from symptom onset, documented bacteremia (positive blood culture) with the same microorganism in joint fluid
- •6. No previous debridement surgeries
- •7. Surgery performed: DAIR
排除标准
- •1. Patients who do not voluntarily and without coercion agree to participate in this clinical trial
- •2. Patients under 18 years of age
- •3. Prosthetic reinfections or a history of multiple debridements
- •4. Known sensitivity or allergic reaction to ethanol, acetic acid, sodium acetate, or benzalkonium chloride
- •5. Diagnosis of Chronic PJI: the presence of fistula or >6 weeks
- •6. Multiple infected implants (>1)
- •7. Medically unfit for DAIR surgery
- •8. Pregnancy
- •9. Legal incapacity
研究者
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