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
| Verified date | March 2020 |
| Source | MolecuLight Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Enrolling by invitation |
| Enrollment | 20 |
| Est. completion date | June 15, 2022 |
| Est. primary completion date | June 15, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Birmingham City University Hospitals | Birmingham | West Midlands |
| Lead Sponsor | Collaborator |
|---|---|
| MolecuLight Inc. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Graft success or failure | Correlation between presence of bacterial fluorescence signature in a wound and failure of a graft. | 1 month | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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