Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Presence of postoperative skin pain within 3 months postoperatively
研究概览
简要总结
This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.
详细描述
This prospective observational study aims to determine the limit of TcPO2 predictive of postoperative cutaneous pain in patients with ankle trauma.
A TcPO2 measurement will be performed preoperatively at the patient's arrival in the emergency room, then every day after the operation for 3 days and finally at the follow-up visits at 3 and 6 weeks.
The cutaneous pain is evaluated by a PSAS self-questionnaire (completed by the patient) and an OSAS questionnaire (completed by the surgeon). These grids evaluate the tolerance and cicatricial quality in the medium and long term by the operator and the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients with surgery of ankle trauma
排除标准
- •Patient who does not agree to participate
- •Patient unable to express agreement (ex: unconscious)
- •Minor patient
- •Major patient under tutorship or curatorship
结局指标
主要结局
Presence of postoperative skin pain within 3 months postoperatively
时间窗: 0-3 Month
次要结局
- Surgical revision rate at S12 and TcPO2 measurements(3 months)
- Rates of postoperative complications related to S12 surgery and TcPO2 measurements(3 months)
- Preoperative and postoperative day 1 TcPO2 on the injured ankle(Day 1)
- Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture(Day 1)
- Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma(Day 1)
- Preoperative TcPO2 on the injured ankle and contralateral ankle(day 0)
- Patient scar assessment scale (PSAS grid) at S6 and S12(Week 12)
- OSAS Scale (observer scars assessment scale) at S6 and S12(Week 12)