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

Last updated: January 27, 2025
Sponsor: Advanced Medical Solutions Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Silver II Non-Woven Dressing

Clinical Study ID

NCT05045430
Silver II Non-Woven 001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females, age 18 years or above. (Females must not be pregnant and if ofreproductive age should be using contraception).

  • Patients who are able to understand and give informed consent to take part in thestudy.

  • 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 thicknessburn wounds that are infected, or are at high risk of infection , that are moderateto heavy levels of exudate.

  • For Partial Thickness Second Degree Burns that require grafting - only those graftswith single thickness mesh grafts that have X % epithelialization will be enrolled [Note: % epithelization to be added once sites/countries are chosen as this isspecific to the territory where the Silver II Non Woven Dressing study is likely tobe performed].

Exclusion

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, inthe opinion of the Investigator, would interfere with his/her ability to participatein the study;

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Silver II Non-Woven Dressing
Phase:
Study Start date:
July 13, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Queen Elizabeth the Queen Mother Hospital

    Margate, Kent CT9 4AN
    United Kingdom

    Active - Recruiting

  • HMC Health

    London, TW3 3ET
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals City Hospital, Hucknall Rd,

    Nottingham, NG5 1PB
    United Kingdom

    Active - Recruiting

  • University Hospitals Plymouth NHS Trust - Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Berkshire Healthcare NHS Foundation 57-59 Bath Rd,

    Reading, RG30 2BA
    United Kingdom

    Active - Recruiting

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN
    United Kingdom

    Active - Recruiting

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