PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

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.

Study Overview

• Status: Completed
• Conditions: Wound
• Intervention / Treatment: Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bath, United Kingdom
    • Royal United Hospital Bath
  • East Grinstead, United Kingdom
    • Queen Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. Patients who are able to understand and give informed consent to take part in the study.
3. 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.
4. Pressure ulcers that are moderate to high exudate, typically Category 3 and 4.
5. Only one primary wound may be treated per patient for the study.

Exclusion Criteria:

1. Patients who are known to be non-compliant with medical treatment,
2. Patients who are known to be sensitive to any of the device components
3. Subject is pregnant or actively breastfeeding;
4. Subject has a known sensitivity to Silver;
5. Life expectancy of <6 months;
6. 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;
7. Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate); 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.; Other Names: Silvercel (brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 weeks
Change in wound granulation tissue	Change in % of wound granulation tissue.	6 weeks
Percent change in wound size	Percent change in wound size (% change in: volume, area or depth).	6 weeks
Percent change in devitalized tissue	Percent change in devitalized tissue	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Silver I Alginate NonWoven 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No