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

July 21, 2023 updated by: Advanced Medical Solutions Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, TW3 3ET
        • Recruiting
        • HMC Health
        • Contact:
        • Principal Investigator:
          • Ivor Dr Singh, MD MRCGP
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals City Hospital, Hucknall Rd,
        • Contact:
        • Principal Investigator:
          • Skaria Alexander
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • University Hospitals Plymouth NHS Trust - Derriford Hospital
        • Contact:
        • Principal Investigator:
          • Alexandra Bishop
      • Reading, United Kingdom, RG1 5AN
      • Reading, United Kingdom, RG30 2BA
    • Kent
      • Margate, Kent, United Kingdom, CT9 4AN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assigned Intervention
Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silver II Non-Woven Dressing
Device: Silver II Non-Woven Dressing

Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver II Non-Woven dressings.

Subjects will be evaluated as follows:

Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over six-week period (per Advanced Medical Solution Product) or until the wound is healed to extent that the use of Silver II Non-Woven dressing is no longer indicated from the time that the patient has been recruited.

The assessment of the presence and reduction of the signs and symptoms of Infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the Silver II Non-Woven Dressing
Time Frame: 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.

Effectiveness (performance) of the Silver II Non-Woven Dressing will be evaluated for efficacy success according to the following success criteria:

Reduction in signs and symptoms of infection from baseline as defined as

The change from the Investigator's opinion of infection being present to no longer being present, or If the Investigator determines infection is still present there is improvement in severity of at least two.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
User satisfaction with the Silver II Non-Woven Dressing.
Time Frame: immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
To establish clinician and user satisfaction Clinician satisfaction with the device (conformability & ease of use) this will be assessed using a Likert type scale. (Very satisfied, Satisfied and not Satisfied)
immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Medical Solutions Ltd.

Collaborators

NAMSA

Investigators

  • Principal Investigator: Jessica Evans, MBBS MRCS, Queen Elizabeth Queen Mother Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silver II Non-Woven 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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