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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166641
• Other study ID #: PJKT2023-007
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Affiliated Hospital of Guangdong Medical University
• Contact: Yiyue Zhong, MD
• Phone: 13726909905
• Email: zyy0803[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5658
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Outcome
• Crush Injuries
• Pressure Ulcer

Intervention

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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Guangdong Medical University

Country where clinical trial is conducted

China, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative acquired pressure injury	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	Mortality	All deaths reported in the study population	Perioperative Period