WoundsNCT02662101
Impact of Oxidized Silver Wound Dressings on Wound Bacteria
A study testing Exsalt SD7, Exsalt T7 Wound Dressing in people with Wounds, run by Exciton Technologies Inc..
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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Wounds
- What is being tested?
- Exsalt SD7, Exsalt T7 Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings
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.
- Conditions
- Wounds
- Being tested
- Exsalt SD7, Exsalt T7 Wound Dressing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exsalt SD7, Exsalt T7 Wound DressingDevice
| Study group | Role | What they receive |
|---|---|---|
| Single arm, exsalt application | Experimental | Not described Receives: Device: Exsalt SD7, Exsalt T7 Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exciton Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsay Kalan, PhD, Study chair, Exciton Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662101
- Sponsor's protocol ID
- Engage-453139_2013
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Microbial Ecology as a Diagnostic Tool to Identify Mode of Action and New Targets for Oxidized Silver Wound Dressings
- ClinicalTrials.gov ID
- NCT02662101
- Acronym / sponsor ID
- Engage-453139_2013
- Conditions
- Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Exciton Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, exsalt application | Experimental | Device: Exsalt SD7, Exsalt T7 Wound Dressing |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exsalt SD7, Exsalt T7 Wound Dressing | Device | Single arm, exsalt application |
Primary outcome
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.
1 secondary outcome
Observe wound progression
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Kalan, PhD study chair
Exciton Technologies
Questions about this trial
What is this clinical trial studying?
A study testing Exsalt SD7, Exsalt T7 Wound Dressing in people with Wounds, run by Exciton Technologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe microbes in the wound (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.