PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
Research type
Research Study
Full title
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
IRAS ID
319928
Contact name
Naama Giwnewer
Contact email
Sponsor organisation
Advanced Medical Solutions Limited.
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This study is to demonstrate how well the Silver I Alginate Non-Woven Dressing (Hydro-Alginate) - referred to from now on as 'Silver I dressing' - works when used to treat patients with moderate to heavily exuding chronic (wounds that do not progress through normal and timely healing) and acute (injury to the skin that occurs suddenly rather than over time) wounds consisting of pressure ulcer and donor sites (the area left where a piece of skin has been taken to cover a wound on another part of the body) that are infected, or are at high risk of infection.
The Silver I dressing is approved for use in UK and participants will be treated with the dressing as per standard of care. The data collected from this study will be used to demonstrate how well the dressing manages these wound types in real life setting, confirm the safety of the dressing as well as establish user satisfaction.
The study will enrol 60 participants across a maximum of 5 sites in the UK who specialise in wound care, these sites will either be in a hospital or community care setting. Participants will have their wounds treated with the Silver I dressing as per standard of care and will be reviewed weekly for up to 4 weeks or until their wound heals. Participants will then be required to attend a follow up visit on Week 6, to ensure there has been no reappearance of infection. The weekly review of the wound will include wound progression and odour assessment, participant pain, signs of infection. A subgroup of participants will have their wounds photographed at each visit to show wound progression.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/PR/0054
Date of REC Opinion
2 Feb 2023
REC opinion
Further Information Favourable Opinion