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
About this trial
This is an interventional basic science trial for Wounds
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.
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
NCT ID
NCT02662101
First Posted
January 20, 2016
Last Updated
January 20, 2016
Sponsor
Exciton Technologies Inc.
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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