Trial Outcomes & Findings for Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds (NCT NCT03091361)
NCT ID: NCT03091361
Last Updated: 2020-01-18
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
30 participants
3 months
2020-01-18
Participant Flow
Participant milestones
| Measure |
All Patients (Imaging/no Intervention)
There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds
Baseline characteristics by cohort
| Measure |
All Patients (Imaging/no Intervention)
n=30 Participants
There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
|
|---|---|
|
Age, Customized
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPPV 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 (Imaging/no Intervention)
n=30 Participants
There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
|
|---|---|
|
Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples
|
100 percentage of PPV of red fluorescence
|
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