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Retrospective Database Review at LTC and SNFs

W

Wound Care Plus

Status

Completed

Conditions

Autofluorescence Imaging
Non-Healing Ulcer of Skin

Treatments

Device: MolecuLight

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

193 participants in 2 patient groups

MolecuLight cohort
Description:
The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment.
Treatment:
Device: MolecuLight
Standard of Care cohort
Description:
Standard of care clinical wound assessment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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