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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Deep Surgical Site Infection
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 3419
- Locations
- 1
- Primary Endpoint
- deep surgical site infection
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients who previously received open posterior instrumented thoracolumbar surgery
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.