Last reviewed · How we verify
NCT04185636
Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X
trial testing MolecuLight i:X imaging in Skin Graft (Allograft)(Autograft) Failure in 20 participants. Status unknown.
15 June 2022
Quick facts
| Lead sponsor | MolecuLight Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 15 January 2021 |
| Primary completion | 15 June 2022 |
| Estimated completion | 15 June 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- MolecuLight i:X imaging
Conditions studied
- Skin Graft (Allograft)(Autograft) Failure — all drugs for Skin Graft (Allograft)(Autograft) Failure →
Sponsor
MolecuLight Inc.
Who can join
18 and older, any sex, with Skin Graft (Allograft)(Autograft) Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04185636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other MolecuLight Inc. trials
Trials by the same sponsor.
- NCT05196880 — Biofilm Correlation and Validation · completed
- NCT05183698 — Point-spectroscopy Trial · unknown
- NCT04207099 — Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care · unknown
- NCT03967405 — A Prospective Evaluation of Clinical Equivalence Between iX and PID · unknown
- NCT03754426 — A Prospective, Pilot Evaluation of Device Equivalence · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04185636 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MolecuLight Inc.
- Last refreshed: 6 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04185636.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing