Risk Factors Associated With Infection After Spine Surgery

NCT ID: NCT05740865

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3419 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2023-01-20

Brief Summary

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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

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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.

Conditions

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Deep Surgical Site Infection Spine Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

open posterior instrumented thoracolumbar surgery

Intervention Type PROCEDURE

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

open posterior instrumented thoracolumbar surgery

Intervention Type PROCEDURE

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

Interventions

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open posterior instrumented thoracolumbar surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fengzeng Jian

Role: STUDY_DIRECTOR

Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Locations

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Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University

Beijing, , China

Site Status

Countries

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China

References

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Cheng L, Liu J, Lian L, Duan W, Guan J, Wang K, Liu Z, Wang X, Wang Z, Wu H, Chen Z, Wang J, Jian F. 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. Int J Surg. 2023 Aug 1;109(8):2276-2285. doi: 10.1097/JS9.0000000000000461.

Reference Type DERIVED
PMID: 37204435 (View on PubMed)

Other Identifiers

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Neurospine_infection

Identifier Type: -

Identifier Source: org_study_id

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