Evaluation of a silver alginate dressing for wound care
Post-market Surveillance Study to Confirm the Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds
This study is testing a new silver alginate dressing to see if it helps people with chronic and acute wounds heal better and stay clean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Medical Solutions Ltd. Industry-sponsored |
| Locations | 2 sites (Bath and 1 other locations) |
| Trial ID | NCT05690685 on ClinicalTrials.gov |
What this trial studies
This study is designed to confirm the safety and effectiveness of the Silver I Alginate Non-Woven Dressing in managing chronic and acute wounds, including pressure ulcers and donor sites. It is an open-label, multicentre, single-arm clinical evaluation involving 25-30 subjects per wound type. The study aims to assess the dressing's performance in routine clinical use, focusing on wound management, bioburden control, and exudate management. The outcomes will be based on healthcare professionals' assessments of the dressing's acceptability.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with moderate to heavily exuding pressure ulcers or donor site wounds at risk of infection.
Not a fit: Patients with known sensitivities to silver or those with significant medical conditions that may affect treatment compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of a new dressing that improves wound healing and reduces infection risk.
How similar studies have performed: Previous studies on similar wound dressings have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bath and 1 other locations
- Royal United Hospital Bath — Bath, United Kingdom (Recruiting)
- Queen Victoria Hospital — East Grinstead, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Naama Giwnewer, MSc
- Email: naamag@admedsol.co.il
- Phone: 972-506979691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.