An observational study in Deep Surgical Site Infection and Spine Surgery, sponsored by Xuanwu Hospital, Beijing. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Xuanwu Hospital, Beijing · Observational
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.
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 3,419 is above the median of 240 across 2,136 observational studies indexed under Infections.
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Study population included patients who previously receceived open posterior instrumented thoracolumbar surgery due to spine disease (except that spine infection or revision surgery)
patients who previously received open posterior instrumented thoracolumbar surgery
Exclusion Criteria:
this group included patients who developed deep surgical site infection after open posterior instrumented thoracolumbar surgery
Procedure: open posterior instrumented 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
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.
Time frame: within 30 days after the operation
Plan to share: Undecided
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing