Trial Outcomes & Findings for Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds (NCT NCT02682069)
NCT ID: NCT02682069
Last Updated: 2020-02-26
Results Overview
PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,
COMPLETED
NA
30 participants
Baseline
2020-02-26
Participant Flow
Participant milestones
| Measure |
All Patients
There is one arm to this study and all patients will undergo the same procedures.The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations.Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
Baseline characteristics by cohort
| Measure |
All Patients
n=30 Participants
There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.MolecuLight i:X Imaging Device: The intended use of the device is to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device will be used as part of the current clinical wound assessment process which may include examination for characteristic signs and symptoms of infection. The device can capture and document either an image or video of the chronic wound where the presence of florescent bacteria appears under violet light illumination.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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30 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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24 Participants
n=5 Participants
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Region of Enrollment
United States
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30 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: BaselinePPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,
Outcome measures
| Measure |
All Patients
n=30 Participants
There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
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|---|---|
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Positive Predictive Value (PPV) - Ability of Fluorescence Imaging With the MolecuLight i:X to Predict Presence of Bacterial Loads of 104 CFU/g and Greater
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100 Percentage of PPV
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Adverse Events
All Patients (Imaging/no Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place