Acute wounds
Conditions
Interventions
Group 1: Wounds are treated with negative pressure wound thearpy and at the study end will be assigned to wounds whose healing progress was influenced by infection.
Group 2: Wounds are treated with ne
Sponsors
PAUL HARTMANN AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to determine the appropriate time point for switching to an alternative therapy the wound status will be evaluated by means of a wound score. This should be done at the first dressing application, at all dressing changes and at the last dressing application. In addition, wound exudates will be collected during every dressing change and analysed biochemically. Physiologic status will be determined by routine laboratory-analysed findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary endpoints not defined | — |
Countries
Germany
Contacts
Public ContactTim Pohlemann
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie Universitätsklinikum des Saarlandes
Outcome results
None listed