WoundNCT05045430
PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
A study testing Silver II Non-Woven Dressing in people with Wound, run by Advanced Medical Solutions Ltd. at 8 sites in 2 countries.
Trial summary
Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- Silver II Non-Woven Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Jul 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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;
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom7 sites
Castlegate and Derwent Surgery
Cockermouth, CA13 9HT
HMC Health
London, TW3 3ET
Queen Elizabeth the Queen Mother Hospital
Margate, Kent, CT9 4AN
Nottingham University Hospitals City Hospital, Hucknall Rd,
Nottingham, NG5 1PB
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
Berkshire Healthcare NHS Foundation 57-59 Bath Rd,
Reading, RG30 2BA
Royal Berkshire Hospital
Reading
About this study
Official title: Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds
Read the detailed description
The design of the study is an open-label, multicentre, single arm clinical trial in subjects with 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 and partial thickness burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.
- Conditions
- Wound
- Being tested
- Silver II Non-Woven Dressing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver II Non-Woven DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Silver II Non-Woven Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To establish clinician and user satisfaction Clinician satisfaction with the device (conformability \& ease of use) this will be assessed using a Likert type scale. (Very satisfied, Satisfied and not Satisfied)
Measured: immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start13 Jul 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Parthiban Vinayakam, Principal investigator, Queen Elizabeth Queen Mother Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045430
- Sponsor's protocol ID
- Silver II Non-Woven 001
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
- ClinicalTrials.gov ID
- NCT05045430
- Acronym / sponsor ID
- Silver II Non-Woven 001
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds
Detailed description
The design of the study is an open-label, multicentre, single arm clinical trial in subjects with 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 and partial thickness burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Intervention | Experimental | Device: Silver II Non-Woven DressingSubjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silver II Non-Woven Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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].
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver II Non-Woven DressingAssigned 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. | Device | Assigned Intervention |
Primary outcome
Effectiveness of the Silver II Non-Woven Dressing
Time frame: 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.
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.
1 secondary outcome
User satisfaction with the Silver II Non-Woven Dressing.
Time frame: immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parthiban Vinayakam principal investigator
Queen Elizabeth Queen Mother Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver II Non-Woven Dressing in people with Wound, run by Advanced Medical Solutions Ltd. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Silver II Non-Woven Dressing (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.