Pressure Ulcer Development Device Related

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.

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Key information

Conditions

Pressure Ulcer Cardiovascular Diseases Embolism and Thrombosis Pressure Ulcer Prevention Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis Venous Thrombosis Deep (Limbs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pressure ulcer incidence

Time frame: 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

Time frame: 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 outcomes

Risk factors for pressure ulcer development

Time frame: 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

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Registry information

Official study title

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

Acronym: Pneumatic

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: May 14, 2026
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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