Evaluating the safety and effectiveness of Silver II Non-Woven Dressing for wound care

Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

This study is testing if Silver II Non-Woven Dressing can safely help heal different types of infected wounds in patients over a 6-week treatment period.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Advanced Medical Solutions Ltd. (Industry-sponsored)
• Locations: 6 sites (Margate, Kent and 5 other locations)
• Trial ID: NCT05045430 on ClinicalTrials.gov

What this trial studies

This study is designed to confirm the ongoing safety and performance of Silver II Non-Woven Dressing in patients with chronic and acute wounds. It is an open-label, multicenter, single-arm clinical trial that includes subjects with various types of infected wounds, such as pressure ulcers, leg ulcers, and burns. Participants will receive the dressing for a 6-week treatment period, during which the study will assess the improvement in signs and symptoms of infection without re-infection. The findings will provide valuable data on the effectiveness of this dressing in managing wound care.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with infected chronic or acute wounds that have moderate to heavy exudate.

Not a fit: Patients with wounds that are not infected or do not have a high risk of infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved wound healing and reduced infection rates for patients with chronic and acute wounds.

How similar studies have performed: Other studies have shown promising results with similar wound care approaches, indicating potential for success in this study.

Eligibility criteria

Inclusion Criteria:

* Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
* Patients who are able to understand and give informed consent to take part in the study.
* Have one or more of the following: Pressure ulcer, Leg ulcer, 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 burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate.
* For Partial Thickness Second Degree Burns that require grafting - only those grafts with single thickness mesh grafts that have X % epithelialization will be enrolled \[Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed\].

Exclusion Criteria:

* Patients who are known to be non-compliant with medical treatment,
* Patients who are known to be sensitive to any of the device components
* Subject is pregnant or actively breastfeeding;
* Subject has a known sensitivity to Silver;
* Life expectancy of \<6 months;
* Maximum burn area of \> 20% total body area. Using the rule of nines assessment tool. \[Note: criteria to be confirmed once sites/countries are chosen\]
* Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study;

Where this trial is running

Margate, Kent and 5 other locations

• Queen Elizabeth the Queen Mother Hospital — Margate, Kent, United Kingdom (Recruiting)
• HMC Health — London, United Kingdom (Recruiting)
• Nottingham University Hospitals City Hospital, Hucknall Rd, — Nottingham, United Kingdom (Recruiting)
• University Hospitals Plymouth NHS Trust - Derriford Hospital — Plymouth, United Kingdom (Recruiting)
• Royal Berkshire NHS Foundation Trust — Reading, United Kingdom (Recruiting)
• Berkshire Healthcare NHS Foundation 57-59 Bath Rd, — Reading, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Jessica Evans, MBBS MRCS — Queen Elizabeth Queen Mother Hospital
• Study coordinator: Danielle King, BSc (hons)

Conditions Wound