Retrospective Database Review at LTC and SNFs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-06-19

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.

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Detailed Description

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Conditions

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Non-Healing Ulcer of Skin Autofluorescence Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MolecuLight cohort

The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment.

MolecuLight

Intervention Type DEVICE

Point-of-care fluorescence imaging of high bacterial loads

Standard of Care cohort

Standard of care clinical wound assessment.

No interventions assigned to this group

Interventions

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MolecuLight

Point-of-care fluorescence imaging of high bacterial loads

Intervention Type DEVICE

Other Intervention Names

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Autofluorescence imaging

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No