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Pressure Ulcer Development Device Related (Pneumatic)

8. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

4500

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pressure ulcer incidence
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Risk factors for pressure ulcer development
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assuta Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2016

Primær fullføring (Faktiske)

31. januar 2026

Studiet fullført (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først innsendt

2. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ASMC 31-26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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