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NCT03540004

Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds

Status unknown Last updated 6 March 2020
What this trial tests

trial testing MolecuLight i:X Imaging Device in Wound in 367 participants. Status unknown.

Timeline
23 May 2018
Primary endpoint
9 April 2019
30 December 2020

Quick facts

Lead sponsorMolecuLight Inc.
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment367
Start date23 May 2018
Primary completion9 April 2019
Estimated completion30 December 2020
Sites14 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

MolecuLight Inc.

Who can join

18 and older, any sex, with Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial.
    Le L, Baer M, Briggs P, Bullock N, et al · · 2021 · cited 75× · PMID 32870774 · DOI 10.1089/wound.2020.1272
  2. Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden.
    Serena TE, Harrell K, Serena L, Yaakov RA. · · 2019 · cited 50× · PMID 31166857 · DOI 10.12968/jowc.2019.28.6.346
  3. Rapid Diagnosis of <i>Pseudomonas aeruginosa</i> in Wounds with Point-Of-Care Fluorescence Imaing.
    Raizman R, Little W, Smith AC. · · 2021 · cited 47× · PMID 33670266 · DOI 10.3390/diagnostics11020280
  4. Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers.
    Armstrong DG, Edmonds ME, Serena TE. · · 2023 · cited 35× · PMID 36708275 · DOI 10.1111/iwj.14080
  5. Uncovering the high prevalence of bacterial burden in surgical site wounds with point-of-care fluorescence imaging.
    Sandy-Hodgetts K, Andersen CA, Al-Jalodi O, Serena L, et al · · 2022 · cited 25× · PMID 34962067 · DOI 10.1111/iwj.13737
  6. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations.
    Johnson J, Johnson AR, Andersen CA, Kelso MR, et al · · 2024 · cited 23× · PMID 37039975 · DOI 10.1007/s40615-023-01584-8
  7. Are Semi-Quantitative Clinical Cultures Inadequate? Comparison to Quantitative Analysis of 1053 Bacterial Isolates from 350 Wounds.
    Serena TE, Bowler PG, Schultz GS, D'souza A, et al · · 2021 · cited 23× · PMID 34359322 · DOI 10.3390/diagnostics11071239
  8. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: <i>Post hoc</i> Analysis of 350 Chronic Wounds.
    Serena TE, Gould L, Ousey K, Kirsner RS. · · 2022 · cited 16× · PMID 34714159 · DOI 10.1089/wound.2021.0146

Verify or expand the search:

Other trials of MolecuLight i:X Imaging Device

Trials testing the same drug.

Other recruiting trials for Wound

Currently open trials in the same condition.

Other MolecuLight Inc. trials

Trials by the same sponsor.

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Data sources for this page

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