Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Bioimpedance around the incision.
研究概览
简要总结
Abdominal surgical incisions often lead to superficial surgical site infection (SSI). SSI is characterized by heat (calor), pain (dolor), redness (rubor), and swelling (tumor). The aim of this study is to measure calor, rubor and tumor with electronic sensors. Therefore, a multisensory patch is proposed which measures the tissue surrounding the incision once per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •The subject requires acute abdominal surgery due to perforation of the intestinal tractus (i.e., contamination upfront).
- •The subject's incision is closed with either sutures or staples (by primary intention).
- •The subject is 18 years or older.
- •The subject can understand the patient information/ consent form and is capable of making his/her own decision.
- •The subject is accompanied by an acquaintance who can give the second consent.
排除标准
- •The subject has a known allergy to (silicon) adhesives.
- •The subject states to be pregnant or planning to become pregnant.
- •The subject receives medication that is contraindicated to excessive light exposure (e.g. Tetracylines, Doxycycline, Phenothiazines, Dacarbazine, Ketoprofen, Lomefloxacin). This criterion will be implemented in order to exclude the possibility of local skin irritation from prolonged irradiation by LED-light.
- •The subject has an implantable device with a battery (i.e. pacemaker or other active implant).
- •The subject has tattoos on the abdomen.
研究组 & 干预措施
SeaPatch
Daily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital.
干预措施: SEAPatch (Device)
结局指标
主要结局
Bioimpedance around the incision.
时间窗: From day 1 post-operative up to 14 days post-operative
Bioimpedance in resistance and reactance at multiple locations around the incision.
Skin temperature around the surgical incision.
时间窗: From day 1 post-operative up to 14 days post-operative
Skin Temperature in degrees Celsius at multiple locations around the incision.
PPG around the surgical incision.
时间窗: From day 1 post-operative up to 14 days post-operative
Reflective PPG in 3 different wavelengths around the surgical incision.
次要结局
未报告次要终点