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
Summary of Research
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.
Summary of Results
Thank you We would like to sincerely thank everyone who took part in this study. Your time, commitment and willingness to share your experiences made this research possible. We appreciate your valuable contribution and hope this summary helps you understand what we learned.About the study
Study 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 This study was carried out by researchers from Queen Victoria Hospital NHS Foundation Trust and Bath Royal United Hospitals NHS Foundation Trust, and was sponsored and funded by Advanced Medical Solutions Limited, who supported the design, conduct and reporting of the study. Any competing interests have been declared according to research guidelines.
The study took place between December 2023 and July 2025.Why was this research needed?
Many people have wounds that produce fluid (known as wound exudate). These include both acute wounds, such as skin graft donor sites, and chronic wounds, such as pressure ulcers. Managing these wounds can be challenging, particularly when there is an infection or a high risk of infection. Excess wound fluid and infection can slow healing, increase discomfort, and make wound care more difficult.
This study was carried out to evaluate how well Silver I Alginate Non-Woven Dressing performed when used to treat moderate to heavily exuding donor sites and pressure ulcers, where infection was present or there was an increased risk of infection. The researchers wanted to understand whether the dressing could effectively manage wound fluid, support healing, and be suitable for use in these types of wounds.What questions did the study aim to answer?
The study explored:
• Whether Silver I Alginate Non-Woven Dressing improved the wound, including the presence of healthy tissue types in the wound, wound size and signs of infection
• Change in wound pain over time
• Change in wound odour over time
• Clinician satisfaction
• Whether there were any unwanted effects or safety concerns.Who took part?
A total of 56 participants took part in the study. Participants were 18 years or older with a pressure ulcer or donor site that was infected or at increased risk of infection and that had moderate to heavy levels of exudate. Participants were recruited from 2 hospitals.What happened during the study?
Participants had their wounds assessed and study dressing applied at visit 1, and were asked to attend weekly follow-up visits for 4 weeks where the dressing was changed and wound assessments performed. They were then followed up at 6 weeks to assess the final wound status.Were there any side effects or problems?
Most participants completed the study without any serious problems. Some participants experienced some superficial skin removal on dressing change, poor wound healing or exudate leakage, which were mild or moderate in severity and managed appropriately. No unexpected safety concerns were identified.What did the study find?
Overall the study found that:
• 97.9% of wounds decreased in size with an increase in healing tissue types and reduction in signs of infection
• Wound pain was significantly reduced, from a score of 4.1/10 at the start of treatment to 1.8/10 at the end of follow up.
• 87.5% of wounds had no odour at the end of follow up
• Clinicians were satisfied or very satisfied with the dressing for over 95% of subjects treated
These findings suggest that the Silver I Alginate Non-Woven Dressing is effective and safe, progressing wound healing in both pressure ulcers and donor sites.
It is important to note that every study has limitations. For example, the small sample size of this study and subjective nature of some endpoints, meaning more research may be needed for the findings to be applied more widely.How will these findings help?
This research improves our understanding of how Silver I Alginate Non-Woven Dressing performs when used to treat moderately to heavily exuding donor sites and pressure ulcers where there is infection or increased risk of infection. The findings may help healthcare professionals make informed decisions about wound care and guide future research.What happens next?
The research team plans to present the results at conferences, share findings with healthcare professionals and carry out further research to answer remaining questions, including the use of this dressing in children.Where can I found out more?
If you would like more information about this study, please contact:
Sponsor contact: Charlotte Moss
Organisation: Advanced Medical Solutions
Email: charlotte.moss@admedsol.comREC name
London - Chelsea Research Ethics Committee
REC reference
23/PR/0054
Date of REC Opinion
2 Feb 2023
REC opinion
Further Information Favourable Opinion