PMCF Study of Silver II Non-Woven Wound Dressing V1
Research type
Research Study
Full title
Post market surveillance study to confirm the ongoing safety and performance of Silver II Non-woven dressing in chronic and acute wounds
IRAS ID
301473
Contact name
Jessica Evans
Contact email
Sponsor organisation
Advanced Medical Solutions Limited.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
The design of the study is an open-label, multicentre, single arm clinical trial. Participants will have 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 partial and Partial Thickness Burns.
This is a Post Market Clinical Follow Up Study and the performance data from this study aims to show successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period in the wound types mentioned above. It also aims to show product safety, wound healing progression, decrease in participant pain and clinician satisfaction with the Silver II Non-Woven Dressing.
This study will be conducted at UK sites who specialise in wound care in both a hospital and community care setting.
Participants will have their wounds treated with Silver II Non-Woven dressing and will be evaluated at a weekly dressing change for up to 6 weeks or until the wound has healed. In the event the wound heals early, a follow up visit on week 6 will still be required to ensure there has been no resurgence of infection. The weekly evaluation will include Wound Assessment, Participant Pain Score, Assessment of Signs and Symptoms of infection and a Clinician Satisfaction Survey. A subset of participants will have their wounds photographed at each visit to show wound progression.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0069
Date of REC Opinion
25 Apr 2022
REC opinion
Further Information Favourable Opinion