PHMB wound dressings for prevention of wound infections
Phase 4
Recruiting
- Conditions
- acute and chronic wounds with risk for infection
- Registration Number
- DRKS00030103
- Lead Sponsor
- Dr. Ausbüttel & Co. GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 264
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
- patient not able to consent
- patient not able to report adverse events
- terminal illness with < 6 month life expectancy
- malignant lesions of the skin
- known hypersensitivity to PHMB, Polyurethane, Polyacrylate, Silicone
- systemic infection which is treated with antibiotics
- wound infection at time point of inclusion
- bite wound
- participation in other study
- pregnancy or lactation
- wound size >= 250 cm2
- deep wounds which have to be treated with an additional wound filler
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Wound size: changes in relative wound area (W.A.R.) in %.<br>Wound situation, changes in: pain (dressing change and general), wound odour, exudate amount, peri-wound skin (reduction of maceration), dressing intervals<br>Prevention of wound infection or need for systemic antibiotics, reduction of stationary hosptial visits <br>Satisfaction of users and patients <br>handling of dressing: ease to use<br>skin compatibility<br>subjective valuation of wound dressing<br>numkber of incidences, severe adverse events, corrective actions, recalls.