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临床试验/NCT06068972
NCT06068972已完成不适用

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

Wound Care Plus, LLC1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
193
试验地点
1
主要终点
Proportion of wounds healed

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Proportion of wounds healed

时间窗: 12-weeks

Time to healing among wounds healed during study period

时间窗: 2019-2022

次要结局

  • Occurrence of wound-related infection, infection complications, antimicrobial use over the study period(2019-2022)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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