Risk Factors Associated With Infection After Spine Surgery

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Completed
CT.gov ID
NCT05740865
Collaborator
(none)
3,419
1
132.6
25.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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 Design

Study Type:
Observational
Actual Enrollment :
3419 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Both group previously received open posterior instrumented thoracolumbar surgery in 4 centers

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University Beijing China 100053

Sponsors and Collaborators

  • Xuanwu Hospital, Beijing

Investigators

  • Study Director: Fengzeng Jian, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT05740865
Other Study ID Numbers:
  • Neurospine_infection
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023