Retrospective Database Review at LTC and SNFs

Non-Healing Ulcer of Skin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068972
• Other study ID #: 22-001
• Status: Completed
• Start date: April 20, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: September 2023
• Source: Wound Care Plus, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: June 19, 2023
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autofluorescence Imaging
• Non-Healing Ulcer of Skin

Intervention

Device:
• MolecuLight
Point-of-care fluorescence imaging of high bacterial loads

Locations

Country	Name	City	State
United States	Wound Care Plus, LLC	Blue Springs	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Wound Care Plus, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of wounds healed		12-weeks
Primary	Time to healing among wounds healed during study period		2019-2022
Secondary	Occurrence of wound-related infection, infection complications, antimicrobial use over the study period		2019-2022