Risk Factors Associated With Infection After Spine Surgery

Completed

• Conditions: Spine Surgery; Deep Surgical Site Infection
• Interventions: Procedure: open posterior instrumented thoracolumbar surgery

• Registration Number: NCT05740865
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2023-01-20
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3419

Inclusion Criteria

patients who previously received open posterior instrumented thoracolumbar surgery

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who did not develop deep surgical site infection after thoracolumbar surgery	open posterior instrumented thoracolumbar surgery	this group included patients who did not develop deep surgical site infection after open posterior instrumented thoracolumbar surgery
patients who developed deep surgical site infection after thoracolumbar surgery	open posterior instrumented thoracolumbar surgery	this group included patients who developed deep surgical site infection after open posterior instrumented thoracolumbar surgery

Primary Outcome Measures

Name	Time	Method
deep surgical site infection	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.

Trial Locations

Locations (1)

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University; 🇨🇳 Beijing, China