NCT Number: NCT02662101
Impact of Oxidized Silver Wound Dressings on Wound Bacteria
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
17 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Observe microbes in the wound
Time frame: 4 weeks
The primary outcome variable will be the observations to changes in the composition of microbes after the application of the wound dressing.
Secondary outcomes
-
Observe wound progression
Time frame: 4 weeks
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
Sponsors and collaborators
Lead sponsor
Exciton Technologies Inc.
Industry
Registry information
Official study title
Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jan 25, 2016
- Registry last updated
- Jan 25, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
MolecuLight All-in-One Oxygenation Clinical Utility
NCT07646938
Wounds, Wounds and Injuries
Monroeville, Pennsylvania, United States
View Trial DetailsMolecuLightDX Measurement Feature Clinical Validation
NCT06682923
Wound of Skin, Wounds
Hamilton, Ontario, Canada
View Trial DetailsHybrid Simulation Training on Nursing Students
NCT06761690
Wound Heal, Wounds
Bursa, Nilüfer, Turkey (Türkiye)
View Trial DetailsThe Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.
NCT05047809
Actinomycetales Infections, Bacterial Infections
Taoyuan City, Taiwan
View Trial Details