PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Sep 7, 2021

Keywords

ClinConnect Summary

The PMS Study is looking at the safety and effectiveness of a special dressing called Silver II Non-Woven Dressing for treating various types of wounds, both chronic (long-lasting) and acute (recently occurring). This dressing is designed to help wounds that are at risk of infection or have moderate to heavy drainage. The study is currently recruiting participants who are at least 18 years old and can understand and agree to take part. Eligible conditions include pressure ulcers, diabetic ulcers, surgical wounds, and certain types of burns, among others.

If you decide to participate, you can expect to receive the Silver II dressing and be monitored to see how well it works in healing your wound. However, there are some important factors to consider before joining. For example, individuals who are pregnant, have certain medical conditions, or are known to be sensitive to silver or the dressing's materials may not be eligible. This study aims to ensure that the dressing is safe and effective, which could help improve wound care for many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
• • 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, Leg ulcer, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate.
• • For Partial Thickness Second Degree Burns that require grafting - only those grafts with single thickness mesh grafts that have X % epithelialization will be enrolled \[Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed\].
• Exclusion Criteria:
• • 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;
• • Maximum burn area of \> 20% total body area. Using the rule of nines assessment tool. \[Note: criteria to be confirmed once sites/countries are chosen\]
• • 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;