Multicenter, randomised in parallel groups, non-inferiority study to compare efficacy and safety of the new” Suprasorb® CNP wound foam dressing with the old” Suprasorb® CNP wound foam dressing during negative pressure wound therapy (FOAM”).
- Conditions
- T14Injury of unspecified body region
- Registration Number
- DRKS00025394
- Lead Sponsor
- ohmann & Rauscher GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 114
Age = 18 years
- Acute or chronic soft-tissue traumatic wound (including soft tissue defects with exposed tendons and/ or non-fractured bones), which is unlikely to heal by a primary intention due to size or other accompanying factors, and for which NPWT seems beneficial as a preparatory stage before skin grafting.
- Patient has signed informed consent
- Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomization and during the whole duration of this study
- Wounds with exposed vessels, vascular anastomoses or viscera
- Unexplored fistulas in the area of the study wound
- Acute bleeding in the area of the study wound
- Necrotic wound
- Untreated osteomyelitis in the area of the study wound
- Wound in the sternum area (except of sternal wound infections after surgical debridement)
- Known intolerance or allergy to the product or any of its ingredients
- System coagulation disorders (increased risk of bleeding)
- Any other medical condition, which may have impact of the success of the study treatment and / or interpretation of the study results (e.g. diabetes, peripheral arterial disease, chronic venous disease).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of the wounds, ready for a skin grafting after 4 weeks of the NPWT
- Secondary Outcome Measures
Name Time Method - Time to achieved wound bed readiness for a skin grafting<br>- Wound area changes over time<br>- Change of fibrinous / granulation tissue rate in the wound bed<br>- Infection rate (total, rates of superficial and deep infections) and change of wound infection status during the study. <br>- Product safety (defined by rate of product-related complications)<br>- Change of wound exudation and presence of peri-wound edema<br>- Change in patients’ pain (measured by VAS scale) and patients’ need for anesthetics (assessed by rate of pain medication prescription)<br>- Product usability (assessed by means of user questionnaire)