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
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.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 II Non-woven Dressing in chronic and acute wounds This study was carried out by researchers from 11 sites in the UK and South Africa, 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 July 2022 and October 2025.Why was this research needed?
Many people have wounds that produce fluid (known as wound exudate). These include both acute wounds, such as post-operative surgical wounds, graft and donor sites, trauma wounds and superficial burns, and chronic wounds, such as pressure ulcers, leg ulcers, diabetic ulcers and cavity wounds. 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 II Non-Woven Dressing performed when used to treat moderate to heavily exuding 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, 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 II 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
• Dressing usage over time
• Clinician satisfaction
• Whether there were any unwanted effects or safety concerns.Who took part?
A total of 278 participants took part in the study. Participants were 18 years or older with an indicated wound that was infected or at increased risk of infection and that had moderate to heavy levels of exudate. Participants were recruited from 11 hospitals across the UK and South Africa.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 poor wound healing, pain, exudate leakage, and possible allergic reaction, 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:
• 93.9% of wounds decreased in size with an increase in healing tissue types and reduction in signs of infection
• A total of 204 patients had no wound infection at endpoint, an increase from 33 patients at baseline.
• Wound pain was significantly reduced, from a score of 4.3/10 at the start of treatment to 1.9/10 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 II Non-Woven Dressing is effective and safe, progressing wound healing in all indicated wound types.
It is important to note that every study has limitations. For example, the small sample size of each wound type in 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 II Non-Woven Dressing performs when used to treat moderately to heavily exuding wounds 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
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0069
Date of REC Opinion
25 Apr 2022
REC opinion
Further Information Favourable Opinion