Risk Factors Associated With Infection After Spine Surgery

Spine Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05740865
• Other study ID #: Neurospine_infection
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: January 20, 2023

Study information

• Verified date: April 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3419
• Est. completion date: January 20, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Deep Surgical Site Infection
• Infections
• Spine Surgery
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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