Retrospective Database Review at LTC and SNFs

NCT06068972 | Completed FDA Device

• 1 other identifier: 22-001
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Healing Ulcer of Skin; Autofluorescence Imaging

Keywords

chronic wounds; bacterial loads; fluorescence imaging; MolecuLight; long-term care; skilled nursing facility

Outcome Measures

Primary Outcomes (2)

• Proportion of wounds healed

  12-weeks

• Time to healing among wounds healed during study period

  2019-2022

Secondary Outcomes (1)

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

  2019-2022

Study Arms (2)

MolecuLight cohort

The MolecuLight bacterial imaging procedure was used in combination with standard of care clinical wound assessment.

Device: MolecuLight

Standard of Care cohort

Standard of care clinical wound assessment.

Interventions

MolecuLight DEVICE

Point-of-care fluorescence imaging of high bacterial loads

Also known as: Autofluorescence imaging

MolecuLight cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wound Care Plus, LLC: lead

Study Sites (1)

Wound Care Plus, LLC

Blue Springs, Missouri, 64015, United States

Location

MeSH Terms

Interventions

Optical Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: April 20, 2022
• Primary Completion: July 12, 2022
• Study Completion: June 19, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)