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CompletedNCT06612177Updated Oct 9, 2024

Elderly Patients Surgical Site Infection Phenotypes Identification

An observational study in Postoperative Infection, Geriatrics and Prediction, sponsored by Weidong Mi. Completed at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Weidong Mi · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
42,532
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

Backgrounds:

With the widespread use of prophylactic antibiotics during perioperative period and the continuous promotion of minimally invasive non-cardiac surgery type such as laparoscopic and thoracoscopic surgery, the incidence of superficial Surgical Site Infection (SSI) has been significantly reduced. Organ/deep SSI has become the dominant type of SSI. Currently, the classification of SSI is limited to the above location from shallow to deep, the epidemiological and clinical characteristics of SSI after non-cardiac surgery in elderly patients are still inadequately defined.

Objectives:

The investigators aimed to determine main risk factors for SSI after non-cardiac surgery among elderly patients in China and to further reveal the clinical attributes of those elderly patients afflicted with SSI.

Methods:

Potential risk factors for developing SSI were selected based on published data, clinical expertise, pathophysiological reasoning, and convenient considerations for future clinical applications. These SSI outcomes were rigorously calibrated by researchers complying with back-to-back principles following uniform diagnostic standards--European Perioperative Clinical Outcome (EPCO) definitions. According to the definitions, SSI in this study consists of three sites: superficial incision, deep incision, and organ/deep. The investigators define the occurrence of any of the above sites as SSI infection. Multivariable logistic regression analysis was used to identify risk factors for SSI. Data from population-based cohort of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive the model. The risk prediction model was derived from the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The investigators performed a nomogram, a complanation model based on the regression model with the graduated line segments as the main body. The discrimination was compared based on the AUC. The calibration was assessed by the calibration intercept and the slope. Decision curve analysis (DCA) was adopted to determine the nomogram's clinical usefulness and net benefit. Latent class analysis (LCA) was further used to explore the population features of SSI. LCA combines the latent variable theory with classified variables to explore the category latent variables behind statistically related classified explicit variables. Utilizing LCA, patients were classified into distinct cluster classifications, with each cluster's traits explained based on clinical factors. All continuous variables in the prediction model were treated as categorical variables before the LCA analysis. The number of categories was ascertained via the Bayesian information criterion (BIC). The lower BIC was also the elbow point which indicates better model fit. When determining the number of latent classes, clinical interpretations were taken into account. To demonstrate the combination of different risk factors in the prediction model, a chord chart and a characteristic data distribution map of subphenotypes were devised.

02

Conditions studied

  • Postoperative Infection
  • Geriatrics
  • Prediction
  • Surgical Site Infection

Keywords

  • the elderly
  • prediction model
  • surgical site infection
  • latent class analysis
03

In context

Surgical Wound Infection

687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.

This study's enrollment of 42,532 is above the median of 240 across 133 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Weidong Mi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients undergoing neurosurgery or cardiac surgery;
  2. Patients with preoperative infections (including pneumonia, SSIs, UTIs, and bloodstream infections);
  3. Uncertain type of operation
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
42,532 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: January 2012 - August 2018

07

Study locations

1 site
  • Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
    Beijing, Beijing Municipality 100853, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Dec 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2024
First posted
Sep 25, 2024
StartActual
Jan 1, 2023
Primary completionActual
Dec 30, 2023
CompletionActual
Jun 30, 2024
Last update
Oct 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06612177
Lead sponsor
Weidong Mi
Responsible party
Weidong Mi (Depatment of Anesthesiology, The First Medical Center, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Sep 25, 2024
Start date
Jan 1, 2023
Primary completion
Dec 30, 2023
Completion
Jun 30, 2024
Last update
Oct 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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