Monocentric two-arm, non-randomized study to investigate biochemical and physiologic parameters and their correlation to the clinical appearance during negative pressure wound therapy with the aim to determine the appropriate moment to switch to the subsequent therapy - Early Switch

PAUL HARTMANN AG0 个研究点目标入组 30 人开始时间: 2013年8月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Men and women at least 18 years old
•- The patient has given his consent which he had signed and dated by himself.
•Patient suffered from a wound which should be treated with the NPWT system Vivano according to the estimation of the investigator and according to the the manufacturer's instructions. Three dressing changes should be planed according to the estimation of the physician.
•- Expectancy of life of the patient should exceed four weeks.

•- Patient suffers from an infection concerning the immune system and/or can be transmitted by blood
•- Patient with known diabetes and Hba1c > 64 mmol/l
•- Patient suffers from an active autoimmune deficiency which is inadequately compensated by therapy at the start of the study.
•- Patient receives cytostatics due to an oncologic disease
•- Patient is immune suppressed due to a preceeding organ transplantation
•- Patient requires dialysis before the start of the study.
•- Patient presents signs of malnutrition, i.e. BMI < 17 and/or albumin level < 25 g/l.
•- Patient suffers from adipositas permagna with a BMI > 40.
•- Patient is according to the investigator not capable of understanding the character, meaning and consequences of the clinical study.
•- Preceeding participation at this study as well as participation at another study within 4 weeks before the start of the study. An exception is the study which had been approved by the ethics commitee by the number 185/08.
•- Patient is pregnant or breast-feeding.

发起方