Risk Factors Associated With Infection After Spine Surgery

Surgical site infection (SSI), particularly deep SSI, is one of the most serious complications after spinal surgery. evaluating the risk of SSI and, correspondingly, prescription of prophylactic measures are extremely important to prevent SSI and avoid potentially devastating consequences. A retrospective study was conducted aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery.

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Key information

Conditions

Deep Surgical Site Infection Spine Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Beijing, 100053, China

About this study

Data of 3,419 patients in 4 hospitals from Jan 1, 2012 to Dec 30, 2021 were retrospectively collected and were evaluated aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery. Clinical knowledge-driven, data-driven and decision tree model was used to identify predictive variables of deep SSI. Internal validation was performed by using bootstrapping methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who previously received open posterior instrumented thoracolumbar surgery

Exclusion criteria

were aged < 18 years;
underwent surgery for the spinal infection, spine revision surgery, or cervical operation;
were diagnosed as superficial SSI;
died in hospital;
diagnosis of SSI was not determined;
had missing data more than 10% were excluded.

Treatment and study plan

open posterior instrumented thoracolumbar surgery

Procedure

Both group previously received open posterior instrumented thoracolumbar surgery in 4 centers

Primary outcomes

deep surgical site infection

Time frame: within 30 days after the operation

deep SSI was defined as an infection occurring within 30 days after the operation involving deep soft tissues along with one of the following criterion: (1)purulent drainage from the deep incision but not from the organ/space component of the surgical site;(2) a deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever >38℃, localized pain, or tenderness, unless site is culture-negative;(3) an abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination;(4) diagnosis of a deep incisional SSI by a surgeon or attending physician. In this study, organ space SSI was also classified as deep SSI due to the same criteria as deep SSI.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Predicting Deep Surgical Site Infection in Patients Receiving Open Posterior Instrumented Thoracolumbar Surgery--- A-DOUBLE-SSI Risk Score: a Large Retrospective Multicenter Cohort Study in China

Important dates

Study start: 2012
Primary completion: 2021
Study completion: 2023
First posted: Feb 23, 2023
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed