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Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device
Sponsor study identifier
observational
20
1 country
1
Study Start
January 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will investigate whether the presence of a bacterial fluorescent signature captured by the MolecuLight i:X can predict a skin graft failure. The MolecuLight i:X is a handheld medical device which enables real-time standard digital imaging and fluorescence imaging of wounds and surrounding healthy skin of patients. When wounds are illuminated in fluorescence mode, collagen and other related proteins in the connective tissue matrix may emit a characteristic green fluorescent signal, while some bacteria may emit a unique red fluorescence signal due to endogenous porphyrin production and others may emit a unique cyan fluorescence signal due to the production of pyoverdine. This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. The images will be used after a 1-month patient follow up to correlate presence of bacterial fluorescence signature to graft failure. The hypothesis is that the presence of a bacterial fluorescence signature increases the likelihood of graft failure. The ability to predict graft failure would provide clinicians with more information on which to base a patient's suitability for a graft (e.g. determining if there is a heavy bacterial load present). This may lead to selection of appropriate therapies before a graft is applied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2019
Actual (reported)December 4, 2019
Actual (reported)January 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Graft success or failure
Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft.
1 month
Economic Analysis
1 month
There will only be 1 group, patients receiving a skin graft and MolecuLight i:X imaging
The MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device.
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Patients presenting at 1 clinical site in the United Kingdom with a wound with a previous infection requiring a skin graft.
Birmingham City University Hospitals
Birmingham, West Midlands, B18 7QH, United Kingdom
Steven Jeffery, MB ChB
Birmingham City University Hospitals
First Submitted
November 29, 2019
First Posted
December 4, 2019
Study Start
January 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 15, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 6, 2020
Record last verified: 2020-03
This study will not make IPD available to other researchers.
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Source: ClinicalTrials.gov.
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