Retrospective Database Review at LTC and SNFs

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Healing Ulcer of Skin; Autofluorescence Imaging
• Intervention / Treatment: Device: MolecuLight

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Blue Springs, Missouri, United States, 64015
      • Wound Care Plus, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult Medicare beneficiaries in the state of Missouri who began receiving wound care (admission period) from Wound Care Plus LLC providers during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-March 2022 (Moleculight cohort).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MolecuLight cohort; The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment.	Device: MolecuLight; Point-of-care fluorescence imaging of high bacterial loads; Other Names: Autofluorescence imaging
Standard of Care cohort; Standard of care clinical wound assessment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wound Care Plus, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: chronic wounds; fluorescence imaging; long-term care; MolecuLight; bacterial loads; skilled nursing facility
• Other Study ID Numbers: 22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect patient confidentiality, the study data are not publicly available; however they are available from the authors upon reasonable request and with permission of Wound Care Plus, LLC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No