Skin Graft (Allograft)(Autograft) Failure Clinical Trial
Official title:
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04951934 -
Prospective Randomized International Study on the Reactivation of Burn Injuries
|
N/A |