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Impact of Oxidized Silver Wound Dressings on Wound Bacteria

Primary Purpose

Wounds

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exsalt SD7, Exsalt T7 Wound Dressing
Sponsored by
Exciton Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wounds

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed or verbal informed consent
  2. >17 yrs and <70 yrs of age
  3. have a chronic wound (defined as >6 weeks, non-healing), with or without clinical signs of infection.
  4. requires visitation or admittance to the clinic and subsequent visits for dressing changes

Exclusion Criteria:

  1. Systemic antibiotics within the last 2 weeks.
  2. known skin sensitivity to any of the dressing components
  3. Poor prognosis and who are unlikely to survive the trial period.
  4. Participating in another concurrent trial.
  5. Exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm, exsalt application

    Arm Description

    Outcomes

    Primary Outcome Measures

    Observe microbes in the wound
    The primary outcome variable will be the observations to changes in the composition of microbes after the application of the wound dressing.

    Secondary Outcome Measures

    Observe wound progression
    The second outcome variables will measure wound progression and healing as measured by a standard wound assessment protocol used in the clinic and recorded with pixelere software

    Full Information

    First Posted
    January 20, 2016
    Last Updated
    January 20, 2016
    Sponsor
    Exciton Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02662101
    Brief Title
    Impact of Oxidized Silver Wound Dressings on Wound Bacteria
    Official Title
    Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Exciton Technologies Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the Canadian health care system. Microbes colonizing a chronic wound play an important role in impeding effective healing. Chronic wounds are colonized by polymicrobial communities and no single organism can be seen as causal. Only a small fraction of wound bacteria are cultured by diagnostic tests and studies have shown little agreement between culture and molecular based approaches, therefore an effective diagnostic for wound microbes is required. It is know that the composition of the microbial community associated with a wound changes as it heals although the causal relationship is somewhat unclear. Although not very effective in treating chronic non-healing wounds, antibiotics are often administered, contributing to concerns of antibiotic resistance. The wound dressings produced by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in reducing biofilm formation in vitro. However, it is not known how these silver salts impact microbial ecology of the wound and the role this plays in wound healing. The objectives of this research are to develop a new diagnostic tool based on molecular characterization of wound sites so as to predict how to best treat wounds and to identify new microbes to be targeted by ETI's technology. This project will utilize molecular microbial ecology for the assessment and evaluation of topical silver interventions, gaining insight into the management of chronic infection. Substantiating the microbiota-modifying effectiveness of silver wound dressings towards increasing clinician and patient understanding to improving clinical outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm, exsalt application
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Exsalt SD7, Exsalt T7 Wound Dressing
    Primary Outcome Measure Information:
    Title
    Observe microbes in the wound
    Description
    The primary outcome variable will be the observations to changes in the composition of microbes after the application of the wound dressing.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Observe wound progression
    Description
    The second outcome variables will measure wound progression and healing as measured by a standard wound assessment protocol used in the clinic and recorded with pixelere software
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed or verbal informed consent >17 yrs and <70 yrs of age have a chronic wound (defined as >6 weeks, non-healing), with or without clinical signs of infection. requires visitation or admittance to the clinic and subsequent visits for dressing changes Exclusion Criteria: Systemic antibiotics within the last 2 weeks. known skin sensitivity to any of the dressing components Poor prognosis and who are unlikely to survive the trial period. Participating in another concurrent trial. Exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lindsay Kalan, PhD
    Organizational Affiliation
    Exciton Technologies
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Oxidized Silver Wound Dressings on Wound Bacteria

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