Pressure Ulcer Development Device Related (Pneumatic)

Assuta Medical Center

Status: Completed

Conditions: Pressure Ulcer; Venous Thrombosis Deep (Limbs); Pressure Ulcer Prevention

Study type: Observational

Funder types: Other

Identifiers

NCT07586748

ASMC 31-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,500 participants in 2 patient groups

Patients with Pressure Ulcer

Description:

Patients admitted to the intensive care unit (ICU) for more than 7 days who received intermittent pneumatic compression therapy and developed a pressure ulcer during hospitalization, identified using ICD diagnostic codes and clinical documentation. Pressure ulcers were classified according to the NPUAP staging system where available. This cohort will be compared with patients exposed to intermittent pneumatic compression who did not develop pressure ulcers to evaluate associated risk factors.

Patients without Pressure Ulcer

Description:

Patients admitted to the intensive care unit (ICU) for more than 7 days who received intermittent pneumatic compression therapy and did not develop pressure ulcers during hospitalization, identified through ICD codes and clinical records. This group serves as the reference cohort for comparison of clinical characteristics and risk factors associated with pressure ulcer development.