Pressure UlcerPneumaticNCT07586748
Pressure Ulcer Development Device Related
An observational study of Pressure Ulcer and Pressure Ulcer Prevention, run by Assuta Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Pressure Ulcer Prevention, Venous Thrombosis Deep (Limbs)
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Keywords
- Pressure Ulcer, Intermittent Pneumatic Compression Devices, Intensive Care Units, Venous Thromboembolism, Risk Factors
- Medical subject headings
- Pressure Ulcer, Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: During prolonged ICU stay (>7 days)
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2016
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586748
- Sponsor's protocol ID
- ASMC 31-26
- Acronym
- Pneumatic
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 30793861Lachmann EA, Rook JL, Tunkel R, Nagler W. Complications associated with intermittent pneumatic compression. Arch Phys Med Rehabil. 1992 May;73(5):482-5.
PubMed 1580778Spear M. Pressure ulcer staging-revisited. Plast Surg Nurs. 2013 Oct-Dec;33(4):192-4. doi: 10.1097/PSN.0000000000000015. No abstract available.
PubMed 24297082Won 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.
PubMed 23549834Nouh 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.
PubMed 30100856Skillman 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.
PubMed 22263320Campbell 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.
PubMed 20797513
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Prevention to Complication: A Silent Risk of Intermittent Pneumatic Compression in Postoperative and Critical Care
- ClinicalTrials.gov ID
- NCT07586748
- Acronym / sponsor ID
- Pneumatic / ASMC 31-26
- Keywords
- Pressure Ulcer, Intermittent Pneumatic Compression Devices, Intensive Care Units, Venous Thromboembolism, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Risk factors for pressure ulcer development
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 30793861Kim 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.
- Background: PubMed 1580778Lachmann EA, Rook JL, Tunkel R, Nagler W. Complications associated with intermittent pneumatic compression. Arch Phys Med Rehabil. 1992 May;73(5):482-5.
- Background: PubMed 24297082Spear M. Pressure ulcer staging-revisited. Plast Surg Nurs. 2013 Oct-Dec;33(4):192-4. doi: 10.1097/PSN.0000000000000015. No abstract available.
- Background: PubMed 23549834Won 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.
- Background: PubMed 30100856Nouh 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.
- Background: PubMed 22263320Skillman 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.
- Background: PubMed 20797513Campbell 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Pressure Ulcer Prevention, run by Assuta Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer incidence (time frame: During prolonged ICU stay (>7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07586748, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.