acute and chronic wounds with risk for infection
Conditions
Interventions
Group 1: Wound dressings of group DracoFoam, observation period 4 weeks, documentation of wound situation every 7 days (+- 2 days). Type of dressing from the group can be chosen by the physician. In c
Sponsors
Dr. Ausbüttel & Co. GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - wound with indication for treatment with a foam dressing - not infected at time point of inclusion - W.A.R. Score >= 3 - written consent of patient - age: >= 18 years - patient can visit on a regular base
Exclusion criteria
Exclusion criteria: - patient not able to consent - patient not able to report adverse events - terminal illness with = 250 cm2 - deep wounds which have to be treated with an additional wound filler
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of wound infections per group (aim is infection prevention by Dracofoam Infekt), measured with TILI-Score 2.0; Status of wound is documented every 7 days over 28 days. Dressing changes can be performed at any necessary occasion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound size: changes in relative wound area (W.A.R.) in %. Wound situation, changes in: pain (dressing change and general), wound odour, exudate amount, peri-wound skin (reduction of maceration), dressing intervals Prevention of wound infection or need for systemic antibiotics, reduction of stationary hosptial visits Satisfaction of users and patients handling of dressing: ease to use skin compatibility subjective valuation of wound dressing numkber of incidences, severe adverse events, corrective actions, recalls. | — |
Countries
Austria, Germany
Outcome results
None listed