Clinical trial NCT06068972: Retrospective Database Review at LTC and SNFs
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Healing Ulcer of Skin
Autofluorescence Imaging
Keywords: chronic wounds
bacterial loads
fluorescence imaging
MolecuLight
long-term care
skilled nursing facility
Lead sponsor: Wound Care Plus, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


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

Primary outcomes:
measure: Proportion of wounds healed
timeFrame: 12-weeks
measure: Time to healing among wounds healed during study period
timeFrame: 2019-2022
Secondary outcomes:
measure: Occurrence of wound-related infection, infection complications, antimicrobial use over the study period
timeFrame: 2019-2022
Other outcomes:
Locations:
city: Blue Springs
country: United States
facility: Wound Care Plus, LLC
state: Missouri
Study officials:
References: