Pressure Ulcer Development Device Related (Pneumatic)
8 de mayo de 2026 actualizado por: Sergio Gabriel Susmallian, Assuta Medical Center
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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
4500
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pressure ulcer incidence
Periodo de tiempo: 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
|
During prolonged ICU stay (>7 days)
|
|
Incidence of Pressure Ulcer
Periodo de tiempo: 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.
|
During prolonged ICU stay (>7 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk factors for pressure ulcer development
Periodo de tiempo: 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
|
Baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2016
Finalización primaria (Actual)
31 de enero de 2026
Finalización del estudio (Actual)
31 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
2 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ASMC 31-26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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