Pressure Ulcers in Knee Replacement Surgery (peripress)

August 8, 2018 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

565

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing knee replacement surgery following chronic joint disease

Description

Inclusion Criteria:

  • Primary knee joint replacement
  • Secondary knee joint replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every day until discharge (expected average of 6 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every day until discharge (expected average of 6 days).
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.
every day until discharge (expected average of 6 days).
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
up to the first 3 days post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Gianfranco Ferrarelli, RN, Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2017

Primary Completion (ACTUAL)

December 13, 2017

Study Completion (ACTUAL)

December 13, 2017

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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