Pressure Ulcer, Pressure Ulcer Prevention, Venous Thrombosis Deep (Limbs)
Conditions
Keywords
Pressure Ulcer, Intermittent Pneumatic Compression Devices, Intensive Care Units, Venous Thromboembolism, Risk Factors
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assuta Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure ulcer incidence | During prolonged ICU stay (>7 days) | Occurrence of a new pressure ulcer during ICU stay in patients exposed to intermittent pneumatic compression, identified using ICD codes and clinical documentation |
| Incidence of Pressure Ulcer | During prolonged ICU stay (>7 days) | Development of a new pressure ulcer during hospitalization in patients admitted to the intensive care unit (ICU) for more than 7 days and exposed to intermittent pneumatic compression devices. Pressure ulcers will be identified using ICD diagnostic codes and confirmed by clinical documentation, and classified according to the NPUAP staging system when available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for pressure ulcer development | Baseline | Association between patient characteristics and risk of developing pressure ulcers during ICU stay, including age, BMI, diabetes, vasopressor use, immobility, and duration of intermittent pneumatic compression |
Outcome results
None listed