Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients

December 4, 2023 updated by: Yiyue Zhong, Affiliated Hospital of Guangdong Medical University

Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients: a Multicenter Prospective Cohort Study

The study aims to effectively identify the risk of intraoperative acquired pressure injuries (IAPI) in surgical patients through a prospective multicenter approach. It combines indicators from commonly used assessment tools and practical experience judgments to construct a comprehensive assessment framework.

By incorporating various indicators, the study aims to improve the accuracy and reliability of identifying patients at risk of IAPI during surgery. This will help clinicians in making informed decisions and implementing preventive measures to minimize the occurrence of pressure injuries.

The multicenter approach ensures a diverse and representative sample of patients from different surgical settings. This increases the generalizability of the study findings and enhances the applicability of the assessment framework across various clinical settings.

The project's methodology involves collecting data on patient demographics, medical history, surgical procedure details, and assessment tool scores. These data points will be analyzed to identify significant risk factors for IAPI and develop a risk prediction model.

The study also takes into consideration practical experience judgments, which acknowledge the importance of clinical expertise in assessing patients' risk of IAPI. This ensures that the assessment framework is not solely reliant on assessment tools but also incorporates the insights of experienced clinicians.

Overall, this prospective multicenter study aims to contribute to the field by providing a comprehensive and practical approach to identify the risk of IAPI in surgical patients. The findings from this study can be utilized in clinical practice to improve patient outcomes and reduce the incidence of pressure injuries during surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5658

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Zhanjiang, Guangdong, China
        • Recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The inclusion and exclusion criteria provided suggest that the study aims to evaluate the clinical characteristic of pressure injury in patients who undergo surgery. The study will include all patients who undergo surgery at the participating setting after study registration. This broad inclusion criteria allows for a diverse patient population to be included in the study.

Description

Inclusion criteria: All patients who underwent surgery procedure at the participating setting after the study registration.

Exclusion criteria: Patients who have already been diagnosed with pressure injury (stage II and above) before undergoing surgery procedure. Patients/relatives/guardians understand the refusal of data to be used for clinically relevant research. Investigators believe that certain patient conditions may affect the efficacy and safety assessment of this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intraoperative acquired pressure injury
Intraoperative acquired pressure injury are wounds that develop during a surgical procedure or while a patient is in the operating room. These ulcers are caused by prolonged pressure on a specific area of the body, which reduces blood flow and leads to tissue damage.
Procedure: Surgical procedure at operating room
A surgical procedure in an operating room is a medical intervention that involves making incisions or using minimally invasive techniques to treat a specific condition or perform a diagnostic procedure. The operating room, also known as the operating theater or surgical suite, is a sterile environment specifically designed to minimize the risk of infection and ensure the safety of both the patient and the surgical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative acquired pressure injury
Time Frame: Perioperative Period
Intraoperative acquired pressure injuries, also known as intraoperative pressure ulcers or surgical pressure injuries, are wounds that develop during a surgical procedure. These injuries occur due to prolonged pressure on specific areas of the body, which disrupts blood flow and leads to tissue damage.
Perioperative Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Perioperative Period
All deaths reported in the study population
Perioperative Period

Collaborators and Investigators

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

Sponsor

Affiliated Hospital of Guangdong Medical University

Investigators

  • Principal Investigator: Yiyue Zhong, MD, Affiliated Hospital of Guangdong Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJKT2023-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data sharing policies and decisions are typically determined by the researchers or organizations conducting the study, in collaboration with any relevant ethical review boards and regulatory bodies.

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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