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临床试验/NCT07586748
NCT07586748已完成不适用

From Prevention to Complication: A Silent Risk of Intermittent Pneumatic Compression in Postoperative and Critical Care

Assuta Medical Center0 个研究点目标入组 4,500 人开始时间: 2016年1月1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
4,500

研究概览

简要总结

Pressure sores, also known as pressure ulcers, are a significant complication among hospitalized patients, particularly those who are immobile or require prolonged care. Intermittent pneumatic compression (IPC) devices are routinely used to prevent deep vein thrombosis (DVT); however, they have been associated with pressure injuries, especially over bony prominences such as the ankles. Furthermore, IPC devices may lead to less commonly recognized complications, including compartment syndrome and bullous lesions. This study aims to assess the incidence and characteristics of pressure sores related to IPC device use, focusing on ankle lesions.

详细描述

This retrospective cohort study aims to evaluate the occurrence of pressure ulcers associated with IPC device use and to identify patient- and treatment-related factors associated with their development. The study will include adult patients hospitalized in surgical wards and/or intensive care units who received IPC therapy during the study period. Data will be extracted from electronic health records, including demographic characteristics, comorbidities (e.g., diabetes mellitus, peripheral vascular disease), clinical status (including hemodynamic support and mobility), and detailed information regarding IPC utilization, such as duration of use and documentation of device application and skin assessments.

The primary outcome is the development of device-related pressure ulcers, defined according to the NPUAP staging system and localized to anatomical areas in contact with IPC sleeves. Secondary analyses will assess the association between duration of IPC exposure, patient risk factors, and ulcer severity.

Statistical analysis will include descriptive statistics and multivariable logistic regression to identify independent predictors of pressure ulcer development, adjusting for clinically relevant confounders. The study also aims to explore potential dose-response relationships between IPC exposure duration and risk of injury.

By improving understanding of IPC-associated pressure ulcers, this study seeks to inform safer thromboprophylaxis practices and support the development of monitoring protocols to mitigate preventable harm while preserving the benefits of mechanical venous thromboembolism prevention.

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

  • Adult patients aged 18 years or older
  • Admission to the intensive care unit (ICU) for more than 7 days
  • Exposure to intermittent pneumatic compression devices during ICU stay
  • Availability of complete electronic medical records, including ICD diagnostic -coding and clinical documentation

排除标准

  • Presence of pressure ulcer at the time of ICU admission
  • ICU stay shorter than 7 days
  • Missing or incomplete clinical data relevant to study variables
  • Severe dermatologic conditions affecting skin integrity
  • Limb amputation or conditions preventing IPC use

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Gabriel Susmallian

Senior surgeon

Assuta Medical Center

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