NL-OMON48030已完成不适用
PJ-013483 FLAGSHIP Transitional Care Study 3 - TRICA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Willing and able to sign informed consent form
- •- Willingness to abstain from visiting a sauna during the study period
- •- Willingness to dry area where the HealthDot is applied in a dipping fashion
- •after washing
- •- Willingness to abstain from flying during the study period of time
- •- Elective surgery
- •- General anesthesia required for surgery
排除标准
- •- General inmates of psychiatric wards, prisons, or other state institutions
- •- Investigator or any other team member involved directly or indirectly in the
- •conduct of the clinical study
- •- Any skin condition, for example prior rash, discoloration, scars or open
- •wounds at the area of investigation of both devices
- •- Pregnant, or breastfeeding
- •- Known to be allergic for the tissue adhesive used in the HealthDot.
- •- Use of topical that is known to influence the skin at the test area (such as
- •medical and non-medical creams or lotions)
- •- Patient with active implantables such as Implantable Cardioverter
- •Defibrilator (ICD) and pacemaker
- •- Unable to understand instructions
- •- Expected participation less than 2 weeks
- •- Left lower rib (place where HealthDot will be applied) is involved in the
- •area of surgery, area of disinfection or area where bandages are needed.
- •- Area on arm where the Elan device is applied is involved in the surgical
- •- Patients with antibiotic resistant infections (e.g. MRSA).
研究者
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PJ-013483 FLAGSHIP Transitional Care Study 3Patients, scheduled for surgery e.g. bariatric and major surgery such as cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC), complex rectal surgery, esophagectomy and pancreatectomy.NL-OMON27909Philips Electronics Nederland B.V., acting through Research, Eindhoven,350
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