Pressure Ulcer Development Device Related

NCT07586748 | Completed

• 1 other identifier: ASMC 31-26
• Study Type: observational
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Pressure Ulcer; Intermittent Pneumatic Compression Devices; Intensive Care Units; Venous Thromboembolism; Risk Factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Risk factors for pressure ulcer development

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Medical Center: lead

Related Publications (7)

• 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.

  PMID: 30793861 BACKGROUND

• Lachmann EA, Rook JL, Tunkel R, Nagler W. Complications associated with intermittent pneumatic compression. Arch Phys Med Rehabil. 1992 May;73(5):482-5.

  PMID: 1580778 BACKGROUND

• Spear M. Pressure ulcer staging-revisited. Plast Surg Nurs. 2013 Oct-Dec;33(4):192-4. doi: 10.1097/PSN.0000000000000015. No abstract available.

  PMID: 24297082 BACKGROUND

• 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.

  PMID: 23549834 BACKGROUND

• 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.

  PMID: 30100856 BACKGROUND

• 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.

  PMID: 22263320 BACKGROUND

• 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.

  PMID: 20797513 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior surgeon

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 14, 2026
• Study Start: January 1, 2016
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05