Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds
The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of Pressure ulcers, Leg ulcers, 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 burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver II Non-Woven dressings. Subjects will be evaluated as follows: Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over six-week period (per Advanced Medical Solution Product) or until the wound is healed to extent that the use of Silver II Non-Woven dressing is no longer indicated from the time that the patient has been recruited. The assessment of the presence and reduction of the signs and symptoms of Infection.
Nianwi Healthcare
Germiston, South Africa
Queen Elizabeth the Queen Mother Hospital
Margate, Kent, United Kingdom
Castlegate and Derwent Surgery
Cockermouth, United Kingdom
HMC Health
London, United Kingdom
Effectiveness of the Silver II Non-Woven Dressing
Effectiveness (performance) of the Silver II Non-Woven Dressing will be evaluated for efficacy success according to the following success criteria: Reduction in signs and symptoms of infection from baseline as defined as The change from the Investigator's opinion of infection being present to no longer being present, or If the Investigator determines infection is still present there is improvement in severity of at least two.
Time frame: No worsening of any signs/ symptoms of infection at 6 weeks or if infection resolved prior to 6 weeks, that no new evidence of infection occurred during the 6 week treatment follow up.
User satisfaction with the Silver II Non-Woven Dressing.
To establish clinician and user satisfaction Clinician satisfaction with the device (conformability \& ease of use) this will be assessed using a Likert type scale. (Very satisfied, Satisfied and not Satisfied)
Time frame: immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
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Nottingham University Hospitals City Hospital, Hucknall Rd,
Nottingham, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, United Kingdom
Berkshire Healthcare NHS Foundation 57-59 Bath Rd,
Reading, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom