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Risk Factors Associated With Infection After Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05740865
Recruitment Status : Completed
First Posted : February 23, 2023
Last Update Posted : April 4, 2023
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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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
Deep Surgical Site Infection Spine Surgery 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
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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 : January 1, 2012
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : January 20, 2023
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05740865


Locations
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China
Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
Beijing, China, 100053
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Director: Fengzeng Jian Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
More Information
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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT05740865    
Other Study ID Numbers: Neurospine_infection
First Posted: February 23, 2023    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Surgical Wound Infection
Disease Attributes
 Pathologic Processes
Wound Infection
Postoperative Complications