NCT06628115已完成不适用
Post-market Study of Cerament V/G in Foot Osteomyelitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
研究概览
简要总结
The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:
• How does the bone infection heal in response to the antibiotic paste?
Participants will:
- Undergo standard surgery to remove dead bone and drain any pus.
- Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks.
- Recieve one week of tablet antibiotics.
- Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
- Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years +
- •Informed consent
- •Operated on for foot sepsis with limb salvage intent.
- •Positive bone biopsy from forefoot or midfoot or positive pus culture from exposed bone
- •Adequate vascularity (1+ palpable pedal pulse, biphasic or triphasic ankle waveforms, or successful revascularisation procedure same admission)
- •Compliant with offloading footwear and diabetic medication
排除标准
- •Allergy or contraindication to gentamicin/vancomycin
- •Life expectancy &amp <1 year
- •Unable to make follow up appointments at study centre.
- •Patients with necrotizing infections
- •Gentamicin or vancomycin resistant organism
- •Untreated peripheral arterial disease in angiosome of wound.
- •Buerger's disease
- •Vasculitides
- •Systemic immunosuppressive therapy
- •Pregnancy
- •Breastfeeding
- •Untreated thyrotoxicosis
- •Mysathenia gravis
- •Calcium metabolism disorder
- •Patients taking metformin with estimated glomerular filtration rate (eGFR) &gt; 30ml/min/1.72m2
研究组 & 干预措施
Cerament
Experimental
Cerament V/G implantation to forefoot or mid foot.
干预措施: cerament V or G (Device)
结局指标
主要结局
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
时间窗: 12 months post-implantion
Clinical osteomyelitis: positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end. Radiological osteomyelitis: osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s). This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
次要结局
- Surgical site infection requiring further course of antibiotics (recorded as yes or no)(12 months post-implantion)
- Major or minor amputation of study limb (recorded as yes or no with amputation details)(12 months post-implantion)
- Serious adverse events related to Cerament V/G (number and type of event are recorded)(12 months post implantation)
- Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)(12 months post-implantation)
- Wound healing (recorded as yes or no)(12 months post-implantation)
- Wound area (measured in cm^2)(12 months post-implantation)
- Quality of life (measured using the EQ-5D questionnaire)(12 months post-implantation)
研究者
研究点 (1)
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