PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

This is an interventional treatment trial for Wound Read More

Inclusion Criteria:

• Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
• Patients who are able to understand and give informed consent to take part in the study.
• Have one or more of the following: Pressure ulcer, Leg ulcer, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate.
• For Partial Thickness Second Degree Burns that require grafting - only those grafts with single thickness mesh grafts that have X % epithelialization will be enrolled [Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed].

Exclusion Criteria:

• Patients who are known to be non-compliant with medical treatment,
• Patients who are known to be sensitive to any of the device components
• Subject is pregnant or actively breastfeeding;
• Subject has a known sensitivity to Silver;
• Life expectancy of <6 months;
• Maximum burn area of > 20% total body area. Using the rule of nines assessment tool. [Note: criteria to be confirmed once sites/countries are chosen]
• Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study;