Deep Surgical Site InfectionNCT05740865
Risk Factors Associated With Infection After Spine Surgery
An observational study of Deep Surgical Site Infection and Spine Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Deep Surgical Site Infection, Spine Surgery
- What is being tested?
- open posterior instrumented thoracolumbar surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,419 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- patients who previously received open posterior instrumented thoracolumbar surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
Beijing, 100053
About this study
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
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.
Read the 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.
- Conditions
- Deep Surgical Site Infection, Spine Surgery
- Being tested
- open posterior instrumented thoracolumbar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open posterior instrumented thoracolumbar surgeryProcedure or surgery
Both group previously received open posterior instrumented thoracolumbar surgery in 4 centers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: open posterior instrumented thoracolumbar surgery | |
| 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 Receives: Procedure: open posterior instrumented thoracolumbar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fengzeng Jian, Study director, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740865
- Sponsor's protocol ID
- Neurospine_infection
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37204435
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05740865
- Acronym / sponsor ID
- Neurospine_infection
- Conditions
- Deep Surgical Site Infection, Spine Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,419 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who developed deep surgical site infection after thoracolumbar surgery | – | Procedure: open posterior instrumented thoracolumbar surgerythis group included patients who developed deep surgical site infection after open posterior instrumented thoracolumbar surgery |
| patients who did not develop deep surgical site infection after thoracolumbar surgery | – | Procedure: open posterior instrumented thoracolumbar surgerythis group included patients who did not develop deep surgical site infection after open posterior instrumented thoracolumbar surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- patients who previously received open posterior instrumented thoracolumbar surgery
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open posterior instrumented thoracolumbar surgeryBoth group previously received open posterior instrumented thoracolumbar surgery in 4 centers | Procedure or surgery | patients who developed deep surgical site infection after thoracolumbar surgery, patients who did not develop deep surgical site infection after thoracolumbar surgery |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 37204435Cheng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengzeng Jian study director
Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Surgical Site Infection and Spine Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deep surgical site infection (time frame: within 30 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05740865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.