Pressure Ulcer Development Device Related (Pneumatic)

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 4500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years or older admitted to the intensive care unit (ICU) for more than 7 days and exposed to intermittent pneumatic compression for thromboprophylaxis. Data are obtained from retrospective electronic health records, including demographic characteristics, comorbidities, and clinical variables. The population is stratified into patients who developed pressure ulcers and those who did not during ICU stay.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with Pressure Ulcer; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure ulcer incidence	Occurrence of a new pressure ulcer during ICU stay in patients exposed to intermittent pneumatic compression, identified using ICD codes and clinical documentation	During prolonged ICU stay (>7 days)
Incidence of Pressure Ulcer	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.	During prolonged ICU stay (>7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for pressure ulcer development	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	Baseline

Collaborators and Investigators

• Sponsor: Assuta Medical Center

Publications and helpful links

General Publications

• Kim JY, Lee YJ; Korean Association of Wound Ostomy Continence Nurses. Medical device-related pressure ulcer (MDRPU) in acute care hospitals and its perceived importance and prevention performance by clinical nurses. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):51-61. doi: 10.1111/iwj.13023.
• Lachmann EA, Rook JL, Tunkel R, Nagler W. Complications associated with intermittent pneumatic compression. Arch Phys Med Rehabil. 1992 May;73(5):482-5.
• Spear M. Pressure ulcer staging-revisited. Plast Surg Nurs. 2013 Oct-Dec;33(4):192-4. doi: 10.1097/PSN.0000000000000015. No abstract available.
• Won SH, Lee YK, Suh YS, Koo KH. Extensive bullous complication associated with intermittent pneumatic compression. Yonsei Med J. 2013 May 1;54(3):801-2. doi: 10.3349/ymj.2013.54.3.801.
• Nouh T, Alsabahi T, Altoijry A, Altuwaijri T. Can intermittent pneumatic compression cause compartment syndrome? Saudi J Anaesth. 2018 Jul-Sep;12(3):488-490. doi: 10.4103/sja.SJA_191_18.
• Skillman J, Thomas S. An audit of pressure sores caused by intermittent compression devices used to prevent venous thromboembolism. J Perioper Pract. 2011 Dec;21(12):418-20. doi: 10.1177/175045891102101203.
• Campbell C, Parish LC. The decubitus ulcer: facts and controversies. Clin Dermatol. 2010 Sep-Oct;28(5):527-32. doi: 10.1016/j.clindermatol.2010.03.010.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Risk Factors; Venous Thromboembolism; Intensive Care Units; Pressure Ulcer; Intermittent Pneumatic Compression Devices
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Skin Diseases; Skin Ulcer; Thromboembolism; Thrombosis; Skin and Connective Tissue Diseases; Venous Thrombosis; Pressure Ulcer; Venous Thromboembolism
• Other Study ID Numbers: ASMC 31-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be publicly available due to institutional and ethical restrictions related to patient confidentiality and data protection. De-identified data may be made available to qualified researchers upon reasonable request and with approval from the relevant institutional review board, in accordance with applicable regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No