Phase
Condition
N/ATreatment
Silver II Non-Woven Dressing
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, age 18 years or above. (Females must not be pregnant and if ofreproductive age should be using contraception).
Patients who are able to understand and give informed consent to take part in thestudy.
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 thicknessburn wounds that are infected, or are at high risk of infection , that are moderateto heavy levels of exudate.
For Partial Thickness Second Degree Burns that require grafting - only those graftswith single thickness mesh grafts that have X % epithelialization will be enrolled [Note: % epithelization to be added once sites/countries are chosen as this isspecific to the territory where the Silver II Non Woven Dressing study is likely tobe performed].
Exclusion
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, inthe opinion of the Investigator, would interfere with his/her ability to participatein the study;
Study Design
Study Description
Connect with a study center
Queen Elizabeth the Queen Mother Hospital
Margate, Kent CT9 4AN
United KingdomActive - Recruiting
HMC Health
London, TW3 3ET
United KingdomActive - Recruiting
Nottingham University Hospitals City Hospital, Hucknall Rd,
Nottingham, NG5 1PB
United KingdomActive - Recruiting
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
United KingdomActive - Recruiting
Berkshire Healthcare NHS Foundation 57-59 Bath Rd,
Reading, RG30 2BA
United KingdomActive - Recruiting
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
United KingdomActive - Recruiting
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