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

NCT05690685 | Completed

• 1 other identifier: Silver I Alginate NonWoven 001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Wound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pain assessment

  6 weeks

• Change in wound odour

  6 weeks

• Ease of use assessment using Likert-type scale

  6 weeks

• Change in wound granulation tissue

  6 weeks

• Percent change in wound size

  6 weeks

Study Arms (1)

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

Device: Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Interventions

Silver I Alginate Non-Woven Dressing (Hydro-Alginate) DEVICE

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.

Also known as: Silvercel (brand name)

Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

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 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.

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;
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Royal United Hospital Bath

Bath, United Kingdom

Location

Queen Victoria Hospital

East Grinstead, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

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: December 21, 2022
• First Posted: January 19, 2023
• Study Start: May 16, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)