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Silver dressing passes safety check for wound care

NCT ID NCT05045430

Disease control Sponsor: Advanced Medical Solutions Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 240 adults with chronic or acute wounds to confirm that a silver-coated dressing (Silver II Non-Woven) is safe and works as intended. Researchers checked for signs of infection and asked clinicians how easy the dressing was to use. The dressing is already on the market, and this study helps ensure it continues to meet safety and performance standards.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Silver II Non-Woven Dressing
What this could lead to
If successful, this could confirm that the dressing is safe and effective for managing wound infections, supporting its continued use in wound care.
What could go wrong
This is a post-market study, not a randomized controlled trial, so results may not prove superiority over other dressings. The primary outcome is based on investigator opinion, which can be subjective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

240 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

decubitus ulcer injury ulcer of lower limbs

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Wound

Contacts and locations

Locations

  • Berkshire Healthcare NHS Foundation 57-59 Bath Rd,

    Reading, RG30 2BA, United Kingdom

  • Castlegate and Derwent Surgery

    Cockermouth, CA13 9HT, United Kingdom

  • HMC Health

    London, TW3 3ET, United Kingdom

  • Nianwi Healthcare

    Germiston, South Africa

  • Nottingham University Hospitals City Hospital, Hucknall Rd,

    Nottingham, NG5 1PB, United Kingdom

  • Queen Elizabeth the Queen Mother Hospital

    Margate, Kent, CT9 4AN, United Kingdom

  • Royal Berkshire Hospital

    Reading, United Kingdom

  • University Hospitals Plymouth NHS Trust - Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

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