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

NCT04185636 | Unknown FDA Device

• 1 other identifier: 18-003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Graft (Allograft)(Autograft) Failure

Keywords

Bacterial fluorescence

Outcome Measures

Primary Outcomes (1)

• Graft success or failure

  Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft.

  1 month

Secondary Outcomes (1)

• Economic Analysis

  1 month

Study Arms (1)

Skin Graft Patients

There will only be 1 group, patients receiving a skin graft and MolecuLight i:X imaging

Device: MolecuLight i:X imaging

Interventions

MolecuLight i:X imaging DEVICE

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.

Skin Graft Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MolecuLight Inc.: lead

Study Sites (1)

Birmingham City University Hospitals

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

Study Officials

• Steven Jeffery, MB ChB

  Birmingham City University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 4, 2019
• Study Start: January 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)