Clinical trial NCT04185636: Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X
Official title: Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Graft (Allograft)(Autograft) Failure
Keywords: Bacterial fluorescence
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at 1 clinical site in the United Kingdom with a wound with a previous infection requiring a skin graft.

Brief summary: 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.

Detailed description: 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 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.

Once a patient has identified as being suitable for the trial, the study will be introduced to them by a member of their circle of care. They will be provided with an informed consent form, provided time to consider the study and have any of their questions answered. The patient will be asked to sign and date the ICF if they choose to participate in the study.The subjects will be recruited for a period of 2 months.

The execution of the full protocol is expected to take approximately 15 minutes during a single clinic visit for each study subject. During the clinic visit, the clinician will treat the patient based on their clinical practice. Prior to the application of the skin graft, the Moleculight 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. Following imaging the skin graft will be applied and treatment will continue as per the clinician's clinical practice.

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. There will be a follow-up with each patient at 1 month after the grafting procedure to ask if the grafting procedure was successful. There will not be any imaging or sampling required at the time of follow-up. The information gathered will be used for post-hoc analysis to assess if the presence of a fluorescence signal at the time of imaging is correlated to graft failure.

Eligibility criteria: Inclusion Criteria:

* Subjects with a wound with previous infection, requiring a skin graft
* 18 years or older

Exclusion Criteria:

* Subject has been treated with an investigational drug within 1 month before enrollment
* Subject is unable or unwilling to provide consent

Primary outcomes:
measure: Graft success or failure
timeFrame: 1 month
Secondary outcomes:
measure: Economic Analysis
timeFrame: 1 month
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham City University Hospitals
state: West Midlands
Study officials:
affiliation: Birmingham City University Hospitals
name: Steven Jeffery, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: