NCT06612177

Brief Summary

This study utilizes Latent Class Analysis (LCA) to identify phenotypes of Surgical Site Infection (SSI) in elderly patients following non-cardiac surgery. By analyzing data from two large cohorts, the research establishes a predictive model that uncovers independent risk factors for SSI, including age, hyperlipidemia, and surgical characteristics. The model, with AUCs ranging from 0.753 to 0.791 across cohorts, offers a calibrated prediction of SSI risk. Furthermore, LCA delineates four distinct SSI subphenotypes, highlighting a critical subgroup with a higher infection rate. This subgroup presents a complex interplay of risk factors, indicating the need for tailored preventive strategies. The study's findings contribute to a nuanced understanding of SSI in elderly surgical patients and pave the way for more targeted infection control measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42,532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

October 9, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

September 21, 2024

Last Update Submit

October 5, 2024

Conditions

Keywords

the elderlyprediction modelsurgical site infectionlatent class analysis

Outcome Measures

Primary Outcomes (1)

  • Elderly Patients Surgical Site Infection Phenotypes Identification

    This study applies Latent Class Analysis to identify SSI phenotypes in elderly post-non-cardiac surgery patients, revealing four distinct subgroups with varying infection risks. The predictive model, validated across two cohorts, underscores the importance of tailored preventive strategies for high-risk subgroups, enhancing SSI management in elderly surgical patients.

    January 2012 - August 2018

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Training set included 42,532 elderly patients treated at the First Medical Center of the Chinese PLA General Hospital (PLAGH) from January 2012 to August 2018.

You may qualify if:

  • Age ≥ 65 years;
  • Patients undergoing surgeries not involving local anesthesia.

You may not qualify if:

  • Patients undergoing neurosurgery or cardiac surgery;
  • Patients with preoperative infections (including pneumonia, SSIs, UTIs, and bloodstream infections);
  • Uncertain type of operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Depatment of Anesthesiology, The First Medical Center

Study Record Dates

First Submitted

September 21, 2024

First Posted

September 25, 2024

Study Start

January 1, 2023

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

October 9, 2024

Record last verified: 2024-09

Locations