Impact of Oxidized Silver Wound Dressings on Wound Bacteria

Wounds Clinical Trial

Official title:

Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662101
• Other study ID #: Engage-453139_2013
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: January 20, 2016
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Exciton Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• Exsalt SD7, Exsalt T7 Wound Dressing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Exciton Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	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	4 weeks	No