Risk Factors Associated With Infection After Spine Surgery

NCT05740865 | Completed

• 1 other identifier: Neurospine_infection
• Study Type: observational
• Target: 3,419
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Surgical Site Infection; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• deep surgical site infection

  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.

  within 30 days after the operation

Study Arms (2)

patients who developed deep surgical site infection after thoracolumbar surgery

this group included patients who developed deep surgical site infection after open posterior instrumented thoracolumbar surgery

Procedure: open posterior instrumented thoracolumbar surgery

patients who did not develop deep surgical site infection after thoracolumbar surgery

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

Procedure: open posterior instrumented thoracolumbar surgery

Interventions

open posterior instrumented thoracolumbar surgery PROCEDURE

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

patients who developed deep surgical site infection after thoracolumbar surgery; patients who did not develop deep surgical site infection after thoracolumbar surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population included patients who previously receceived open posterior instrumented thoracolumbar surgery due to spine disease (except that spine infection or revision surgery)

You may qualify if:

• patients who previously received open posterior instrumented thoracolumbar surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Beijing, 100053, China

Location

Related Publications (1)

• Cheng L, Liu J, Lian L, Duan W, Guan J, Wang K, Liu Z, Wang X, Wang Z, Wu H, Chen Z, Wang J, Jian F. 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. Int J Surg. 2023 Aug 1;109(8):2276-2285. doi: 10.1097/JS9.0000000000000461.

  PMID: 37204435 DERIVED

Study Officials

• Fengzeng Jian

  Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: January 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: January 20, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)