Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X

Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device

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.

Study Overview

• Status: Unknown
• Conditions: Skin Graft (Allograft)(Autograft) Failure
• Intervention / Treatment: Device: MolecuLight i:X imaging

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B18 7QH
      • Birmingham City University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Skin Graft Patients; There will only be 1 group, patients receiving a skin graft and MolecuLight i:X imaging	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft success or failure	Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic Analysis	Estimate the cost benefit of identifying and resolving an infection prior to graft (a. Estimate cost of graft procedure without complications, b. Estimate health care and quality of life cost of graft that becomes infected (initial graft, resolution of infection, secondary graft procedures, etc.), c. Estimate health care and quality of life cost of identifying infection prior to initial graft, resolve infection, and then graft procedure)	1 month

Collaborators and Investigators

• Sponsor: MolecuLight Inc.
• Investigators: Principal Investigator: Steven Jeffery, MB ChB, Birmingham City University Hospitals

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2021
• Primary Completion (ANTICIPATED): June 15, 2022
• Study Completion (ANTICIPATED): June 15, 2022

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Bacterial fluorescence
• Other Study ID Numbers: 18-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will not make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No