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

NCT05045430 | Completed

• 1 other identifier: Silver II Non-Woven 001
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 8

Brief Summary

Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the Silver II Non-Woven Dressing

  Effectiveness (performance) of the Silver II Non-Woven Dressing will be evaluated for efficacy success according to the following success criteria: Reduction in signs and symptoms of infection from baseline as defined as The change from the Investigator's opinion of infection being present to no longer being present, or If the Investigator determines infection is still present there is improvement in severity of at least two.

  No worsening of any signs/ symptoms of infection at 6 weeks or if infection resolved prior to 6 weeks, that no new evidence of infection occurred during the 6 week treatment follow up.

Secondary Outcomes (1)

• User satisfaction with the Silver II Non-Woven Dressing.

  immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

Study Arms (1)

Assigned Intervention

EXPERIMENTAL

Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silver II Non-Woven Dressing

Device: Silver II Non-Woven Dressing

Interventions

Silver II Non-Woven Dressing DEVICE

Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver II Non-Woven dressings. Subjects will be evaluated as follows: Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over six-week period (per Advanced Medical Solution Product) or until the wound is healed to extent that the use of Silver II Non-Woven dressing is no longer indicated from the time that the patient has been recruited. The assessment of the presence and reduction of the signs and symptoms of Infection.

Assigned Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed\].

You may not qualify if:

• 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;

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead
• NAMSA: collaborator

Study Sites (8)

Nianwi Healthcare

Germiston, South Africa

Location

Queen Elizabeth the Queen Mother Hospital

Margate, Kent, CT9 4AN, United Kingdom

Location

Castlegate and Derwent Surgery

Cockermouth, CA13 9HT, United Kingdom

Location

HMC Health

London, TW3 3ET, United Kingdom

Location

Nottingham University Hospitals City Hospital, Hucknall Rd,

Nottingham, NG5 1PB, United Kingdom

Location

University Hospitals Plymouth NHS Trust - Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Berkshire Healthcare NHS Foundation 57-59 Bath Rd,

Reading, RG30 2BA, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Parthiban Vinayakam

  Queen Elizabeth Queen Mother Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: July 13, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); GB (7)