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Completed

NCT Number: NCT03039153

Pressure Ulcers in Knee Replacement Surgery

From the point of view of nursing to know exactly the different risk factors for the onset of pressure ulcers is very important as it allows to accurately orient preventive care interventions.

All the variable that could influence the development of pressure ulcer in patients undergoing knee replacement surgery are identified and collected: age, sex, body max index, risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology of the devices used, such as air mattresses with alternating or static pressure, heel drains, frequency of mobilization carried out by both the patient care), management of eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia, length of stay, the ASA physical status classification system (ASA score), comorbidity, cancer, use of devices for controlling the position of the operated limb (foam valve), the number of physical therapy sessions actually carried out.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Pressure Ulcer Rheumatic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary knee joint replacement
  • Secondary knee joint replacement

Exclusion criteria

  • Cancer patients
  • Adult or Senior with pressure ulcer at the heel

Treatment and study plan

Primary outcomes

  1. Heel Pressure Sores

    Time frame: every day until discharge (expected average of 6 days).

    Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

Secondary outcomes

  1. Heel Pressure Sores of grade ≥2

    Time frame: every day until discharge (expected average of 6 days).

    Numbers of Participants With Heel Pressure Sores of grade ≥2 Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

  2. Pressure Sores in any other site

    Time frame: every day until discharge (expected average of 6 days).

    Numbers of Participants With Pressure Sores in any other site Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

  3. Pain

    Time frame: up to the first 3 days post intervention

    Pain Score on the "Numeric Rating Scale (NRS)". The NRS scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

The Peripheral Nerve Blocks Analgesia in Patients Undergoing Knee Replacement Surgery is a Risk Factor for the Development of Pressure Sores at the Heel? Retrospective Cohort Study

Acronym: peripress

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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