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

Wound Care Plus, LLC1 site in 1 country193 target enrollmentApril 20, 2022

ConditionsNon-Healing Ulcer of Skin Autofluorescence Imaging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Healing Ulcer of Skin
Sponsor: Wound Care Plus, LLC
Enrollment: 193
Locations: 1
Primary Endpoint: Proportion of wounds healed
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 20, 2022

End Date

June 19, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wound Care Plus, LLC

Responsible Party

Sponsor

Eligibility Criteria

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