WoundNCT05690685
PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
A study testing Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in people with Wound, run by Advanced Medical Solutions Ltd. at 2 sites in United Kingdom.
Trial summary
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) 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 I Alginate Non-Woven Dressing (Hydro-Alginate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 May 2023to 31 Jul 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 provide a negative pregnancy test at screening).
- 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 or Donor site wounds that are infected, or are at high risk of infection (in the opinion of the Investigator), that are moderate to heavy levels of exudate.
- Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.
- Only one primary wound may be treated per patient for the study.
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;
- 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;
- Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United Hospital Bath
Bath
Queen Victoria Hospital
East Grinstead
About this study
Official title: Post-market Surveillance Study to Confirm the Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
Read the detailed description
Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites.
The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management.
This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate).
It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses.
The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.
- Conditions
- Wound
- Being tested
- Silver I Alginate Non-Woven Dressing (Hydro-Alginate)
- 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 I Alginate Non-Woven Dressing (Hydro-Alginate)Device
Also called Silvercel (brand name)
Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver I 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 up-to six-week follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Silver I Alginate Non-Woven Dressing (Hydro-Alginate) | Experimental | Subjects will undergo treatment of their chronic or acute wound (Pressure ulcer, and Donor sites) as indicated in the instructions for use with Silver I Non-Woven Dressing Receives: Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Wound progression following 6 weeks (Efficacy)
wound progression from baseline to end of follow-up.
In order to be considered successful in wound progression, at least one of the following must occur in the change from baseline to the end of follow-up:
- Increase in % of wound granulation tissue
- Decrease in wound size (volume, area, or depth) or wound closure
- Decrease in devitalized tissue
In addition to the following:
- Reduction or no signs or symptoms of clinical infection.
Measured: 6 weeks
Subject incidence of any treatment-related adverse events during follow-up period - 6 weeks (Safety)
The primary safety analysis will be the calculation of the subject incidence of any treatment-related adverse events between treatment initiation and the end of follow-up for each patient.
Measured: 6 weeks
Secondary outcomes (8)
Pain assessment
Change in patient pain (using Visual Analog Score for pain-VAS Score) from baseline to end of follow-up.
Min-Max VAS score: 0=no pain to 10=worst pain imaginable. Higher pain VAS score would mean a worse outcome.
Measured: 6 weeks
Change in wound odour
Change in wound odour (using Verbal Numeric Scale- VNS score), from baseline to end of follow-up.
Min-Max score: 0= no odour to 4= Smell is present but is perceived as extremely offensive.
A higher odour VNS score would mean a worse outcome.
Measured: 6 weeks
Ease of use assessment using Likert-type scale
Clinician satisfaction with the device (conformability and ease of use) will be assessed using a Likert-type scale.
Min-Max score: 1=Very easy to 5=Very difficult. A higher score would mean a worse outcome.
Measured: 6 weeks
Change in wound granulation tissue
Change in % of wound granulation tissue.
Measured: 6 weeks
Percent change in wound size
Percent change in wound size (% change in: volume, area or depth).
Measured: 6 weeks
Percent change in devitalized tissue
Percent change in devitalized tissue
Measured: 6 weeks
Rates of individual components of wound progression (primary efficacy endpoint)
Rates of individual components of the primary efficacy endpoint, including:
- Increase in % of wound granulation tissue
- Decrease in wound size (volume, area, or depth) or wound closure
- Decrease in devitalized tissue
- Reduction or no signs or symptoms of clinical infection.
For each of these components, the frequency and proportion of successes will be calculated for each wound type.
Measured: 6 weeks
The number of components of the primary efficacy endpoint experienced by each subject
Descriptive statistics of the number of components of the primary efficacy endpoint experienced by each subject, including:
- Increase in % of wound granulation tissue
- Decrease in wound size (volume, area, or depth) or would closure
- Decrease in devitalized tissue
- Reduction or no signs or symptoms of clinical infection
For each subject, the number of successful primary efficacy endpoint components will be calculated (range: 0 - 4). Subjects missing data on any of the four primary efficacy endpoint components will be excluded from this secondary endpoint analysis. Descriptive statistics will be provided for the number of successful primary efficacy endpoint components for each wound type, treating the number of components as a continuous variable.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start16 May 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690685
- Sponsor's protocol ID
- Silver I Alginate NonWoven 001
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2022
- 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 Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds
- ClinicalTrials.gov ID
- NCT05690685
- Acronym / sponsor ID
- Silver I Alginate NonWoven 001
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Jan 2023 (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 ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
Detailed description
Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites.
The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management.
This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate).
It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses.
The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silver I Alginate Non-Woven Dressing (Hydro-Alginate) | Experimental | Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate)Subjects will undergo treatment of their chronic or acute wound (Pressure ulcer, and Donor sites) as indicated in the instructions for use with Silver I 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 (5 listed)
- Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should provide a negative pregnancy test at screening).
- 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 or Donor site wounds that are infected, or are at high risk of infection (in the opinion of the Investigator), that are moderate to heavy levels of exudate.
- Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.
- Only one primary wound may be treated per patient for the study.
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 I Alginate Non-Woven Dressing (Hydro-Alginate)Also: Silvercel (brand name)Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver I 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 up-to six-week follow-up period. | Device | Silver I Alginate Non-Woven Dressing (Hydro-Alginate) |
Primary outcome
Evaluation of Wound progression following 6 weeks (Efficacy)
Time frame: 6 weeks
wound progression from baseline to end of follow-up. In order to be considered successful in wound progression, at least one of the following must occur in the change from baseline to the end of follow-up: * Increase in % of wound granulation tissue * Decrease in wound size (volume, area, or depth) or wound closure * Decrease in devitalized tissue In addition to the following: • Reduction or no signs or symptoms of clinical infection.
Subject incidence of any treatment-related adverse events during follow-up period - 6 weeks (Safety)
Time frame: 6 weeks
The primary safety analysis will be the calculation of the subject incidence of any treatment-related adverse events between treatment initiation and the end of follow-up for each patient.
8 secondary outcomes
Pain assessment
Time frame: 6 weeks
Change in wound odour
Time frame: 6 weeks
Ease of use assessment using Likert-type scale
Time frame: 6 weeks
Change in wound granulation tissue
Time frame: 6 weeks
Percent change in wound size
Time frame: 6 weeks
Percent change in devitalized tissue
Time frame: 6 weeks
Rates of individual components of wound progression (primary efficacy endpoint)
Time frame: 6 weeks
The number of components of the primary efficacy endpoint experienced by each subject
Time frame: 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in people with Wound, run by Advanced Medical Solutions Ltd. at 2 sites in United Kingdom.
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 5 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 2 sites in United Kingdom. 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?
Evaluation of Wound progression following 6 weeks (Efficacy) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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; AzTrials last refreshed its copy on 6 Nov 2026.