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

Advanced Medical Solutions

Status

Completed

Conditions

Wound

Treatments

Device: Silver II Non-Woven Dressing

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05045430

Silver II Non-Woven 001

Details and patient eligibility

About

Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds

Full description

The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of Pressure ulcers, Leg ulcers, 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 burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;