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

NCT04185636 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-03-06

No results posted yet for this study

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.

Conditions

  • Skin Graft (Allograft)(Autograft) Failure

Interventions

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.

Sponsors & Collaborators

  • MolecuLight Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Jeffery, MB ChB · Birmingham City University Hospitals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-06-15
Completion
2022-06-15
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185636 on ClinicalTrials.gov