Retrospective Database Review at LTC and SNFs

Study Overview
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Brief Summary
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The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. The main outcome studied is healing of ulcers after 12-weeks, along with other outcomes such as occurrence of infection, complications, and antimicrobial use. Medical records from the past were reviewed, where patients receiving the MolecuLight procedure were compared to those who did not.

Official Title
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A Retrospective Database Analysis of the Impact of Fluorescence Imaging of Bacterial Presence, Location, and Load on Wound Healing, Antibiotic Usage, and Infection Related Complications

Conditions
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Non-Healing Ulcer of Skin, Autofluorescence Imaging

Intervention / Treatment
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* Device: MolecuLight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Were first treated by Wound Care Plus LLC during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-Mar 2022 (Moleculight cohort) Received at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period Were treated by a Wound Care Plus LLC provider for at least 4 calendar weeks during the study period Were treated in a SNF or LTC setting during the study admission period Were covered by Medicare of Missouri during the study admission period Had at least one chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period MolecuLight cohort ONLY: at least one MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T Exclusion Criteria: Did not receive at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period Received care from Wound Care Plus LLC for less than 4 calendar weeks during the study admission period Were not treated in a SNF or LTC setting during the study admission period Were not covered by Medicare of Missouri during the study admission period Did not have a chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period MolecuLight cohort ONLY: did not receive a MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MolecuLight cohort<br>The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment. | Device: MolecuLight<br>* Point-of-care fluorescence imaging of high bacterial loads<br>* Other names: Autofluorescence imaging;|
| Standard of Care cohort<br>Standard of care clinical wound assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of wounds healed |  | 12-weeks | 
| Time to healing among wounds healed during study period |  | 2019-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of wound-related infection, infection complications, antimicrobial use over the study period |  | 2019-2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic wounds, bacterial loads, fluorescence imaging, MolecuLight, long-term care, skilled nursing facility