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OpenTrials
Completed

NCT Number: NCT06068972

Retrospective Database Review at LTC and SNFs

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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Key information

Conditions

Non-Healing Ulcer of Skin Autofluorescence Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wound Care Plus, LLC

Blue Springs, Missouri, 64015, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MolecuLight

Device

Point-of-care fluorescence imaging of high bacterial loads

Other names: Autofluorescence imaging

Primary outcomes

  1. Proportion of wounds healed

    Time frame: 12-weeks

  2. Time to healing among wounds healed during study period

    Time frame: 2019-2022

Secondary outcomes

  1. Occurrence of wound-related infection, infection complications, antimicrobial use over the study period

    Time frame: 2019-2022

Sponsors and collaborators

Lead sponsor

Wound Care Plus, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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