Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cutaneous and infectious complications
研究概览
简要总结
Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation
详细描述
Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient over 18 years of age
- •Patient with an ankle joint injury with surgical indication
- •Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture
- •Patient affiliated to a social security system
- •Patient having signed an informed consent
排除标准
- •Patient with chronic respiratory insufficiency
- •Patient with sleep apnea with equipment
- •Patient under long term oxygen therapy
- •Patient with a bilateral ankle fracture
- •Polytrauma patients
- •Pregnant or breastfeeding women or those refusing effective contraception
- •Patient deprived of liberty or under legal protection (guardianship or curatorship)
- •Patient unable to follow the protocol, as judged by the investigator
- •Patient refusing to participate in the study
研究组 & 干预措施
Intervention group (A)
Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization
干预措施: Oxygen (Drug)
Control group (B)
No oxygen therapy during hospitalization
干预措施: no oxygen therapy (Other)
结局指标
主要结局
Cutaneous and infectious complications
时间窗: 6 months
Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion
次要结局
- Observer Scar Assessment Scale (OSAS questionnaire)(12 weeks after surgery)
- Pseudoarthrosis Complication(24 weeks after surgery)
- Revision surgery(6 months after surgery)
- Transcutaneous oxygen pressure measurements (TcPO2)(3 weeks after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(24 weeks after surgery)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(24 weeks after surgery)
- Observer Scar Assessment Scale (OSAS questionnaire)(3 weeks after surgery)
- Observer Scar Assessment Scale (OSAS questionnaire)(6 weeks after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(preoperatively)
- Visual Analogue Scale (VAS) to evaluate ankle pain(24 hours after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(48 hours after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(3 weeks after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(6 weeks after surgery)
- Visual Analogue Scale (VAS) to evaluate ankle pain(12 weeks after surgery)
- Transcutaneous oxygen pressure measurements (TcPO2)(before the initiation of oxygen therapy preoperatively)
- Transcutaneous oxygen pressure measurements (TcPO2)(48hours after surgery)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(pre-operatively)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(48 hours after surgery)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(3 weeks after surgery)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(6 weeks after surgery)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire(12 weeks after surgery)