2024-516578-31-00招募中3 期
Efficacy of nasal oxygen therapy on the reduction of postoperative complications in ankle trauma surgery in at-risk patients: a randomized pilot study
Centre Hospitalier Universitaire De Nantes1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.
研究概览
简要总结
To compare the complication rate of "at risk" patients who underwent trauma surgery of the ankle between 2 groups. Patients with at least one comorbidity and/or complex fracture were defined as "at risk":
- Patient with a comorbidity defined at risk by the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)
- Patient with a complex fracture. Complex fractures are defined as dislocated bimalleolar fractures, trimalleolar fractures, distal quarter leg fractures, tibial pilon fractures, talus fractures and open fractures
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Patient with at least one risk factor for scarring complications such as comorbidity(ies) and/or complex fracture
- •Patient with at least one risk factor for scar complication, such as comorbidity(ies) and/or complex fracture: - Patient with a comorbidity defined as at risk in the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids, etc.). - Patients with complex fractures. Complex fractures include dislocated bimalleolar fractures, trimalleolar fractures, fractures of the distal quarter of the leg, tibial pilon fractures, talus fractures and open fractures.
排除标准
- •Patient with chronic respiratory failure
- •Patient with sleep apnea
- •Patient with a bilateral ankle fracture
- •Patient with polytrauma
- •Patient on long-term oxygen therapy
结局指标
主要结局
Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.
Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.
次要结局
- Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12
- Surgical resumption within 6 months after surgery
- Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24
- Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24
- Measurement of TcPO2 before the start of oxygen therapy pre-operatively, then at H48, W3. These measurements will be performed in a subgroup of 40 patients (20 patients in each subgroup)
- Incremental cost-utility ratio over a 24-week time horizon (QALY assessed by EQ-5D self-questionnaire pre-operatively and at H48, W3, W6 and W12 and W24)
研究者
Coordonnateur
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (1)
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