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

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Jan 17, 2023

Keywords

ClinConnect Summary

The PMS Study is looking at a special type of wound dressing called Silver I Alginate Non-Woven Dressing (Hydro-Alginate) to see how safe and effective it is for treating different kinds of wounds, both new and chronic. This study is currently recruiting participants who are at least 18 years old and have certain types of wounds, such as pressure ulcers or infected donor site wounds that have moderate to heavy drainage. It's important that participants can understand the study and give their consent to join.

If you or a loved one is interested, it's essential to know that to be eligible, participants must not be pregnant or breastfeeding, should not have any known allergies to the dressing's components, and must not have serious medical issues that could affect their ability to participate. Each participant will only have one primary wound treated in this study. Joining this study could help improve wound care for many people, so if you meet the criteria and are interested, it could be a great opportunity to contribute to important research.

Gender

ALL

Eligibility 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.