Clinical trial NCT05045430: PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
Official title: Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2021-09-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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;

Primary outcomes:
measure: Effectiveness of the Silver II Non-Woven Dressing
timeFrame: No worsening of any signs/ symptoms of infection at 6 weeks or if infection resolved prior to 6 weeks, that no new evidence of infection occurred during the 6 week treatment follow up.
Secondary outcomes:
measure: User satisfaction with the Silver II Non-Woven Dressing.
timeFrame: immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Other outcomes:
Locations:
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
state: Kent
city: London
country: United Kingdom
facility: HMC Health
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Hospital, Hucknall Rd,
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust - Derriford Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: Reading
country: United Kingdom
facility: Berkshire Healthcare NHS Foundation 57-59 Bath Rd,
Study officials:
affiliation: Queen Elizabeth Queen Mother Hospital
name: Jessica Evans, MBBS MRCS
role: PRINCIPAL_INVESTIGATOR
References: