Post-operative infections following spinal implant surgery; incidence and risk factors

Perispinal implant infections; incidence, risk factors, surgical site colonization and its relation to systemic antibiotic prophylaxis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN75456114

Enrollment

600

Registered

2023-11-08

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-spinal implant infections Infections and Infestations

Interventions

1. Skin samples from the planned incisional area and nasal samples will be taken at the preoperative visit using an e-swab. The skin samples will be repeated just before surgery. Before wound closure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing spinal implant surgery at the study hospital 2. Primary surgery for the planned spinal surgical level

Exclusion criteria

Exclusion criteria: 1. The presence of a preoperative spinal or peri-spinal infection 2. Ongoing active treatment for any type of malign cancer at the time of surgery

Design outcomes

Primary

Measure	Time frame
Perispinal infections (PSII) will be measured using a predefined definition based on the European Bone and Joint Infection Society (EBJIS) criteria for joint infection; two positive cultures of the same organisms and/or sinus tract with evidence of communication or visualization of implant, and/or subfascial wound purulence will be considered definitive infection. To capture infections follow-ups are scheduled for all patients at 10 days, 3 months, 6 months and 1 year after index surgery.	—

Measure

Time frame

Perispinal infections (PSII) will be measured using a predefined definition based on the European Bone and Joint Infection Society (EBJIS) criteria for joint infection; two positive cultures of the same organisms and/or sinus tract with evidence of communication or visualization of implant, and/or subfascial wound purulence will be considered definitive infection. To capture infections follow-ups are scheduled for all patients at 10 days, 3 months, 6 months and 1 year after index surgery.

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Secondary

Measure	Time frame
1. Risk factors for PSII will be explored by collecting patient-related data perioperatively. The variables included are: 1.1. Age, years 1.2. Sex, male/female 1.3. ASA classification score (I-IV) 1.4. Body mass index 1.5. Comorbidities 1.6. Nicotine use, yes/no 1.7. Immunosuppressing treatment 1.8. Alcohol use/how many glasses of wine/week/month 1.9. Spinal diagnosis 1.10. Surgical levels involved 1.11. Type of implants used 1.12. Intraoperative bleeding, measured in ml 1.13. Length of surgery, measured in minutes 1.14. Hospital length of stay, measured in days 1.15. Pressure wounds, measured using the Norton scale 1.16. Post-operative wound infection and other hospital-acquired infections, yes/no 1.17. Prophylactic antibiotics, dose and type and serum concentration 1.18. Serum Albumin - venous blood sample 1.19. Serum-C-reactive protein - venous blood sample 1.20. Hba1C - venous blood sample 1.21. Plasma - glucose 1.22. Bacterial growth on skin and nasale; test will be taken using e-swabs and cultured on standard media 1.23. Bacterial growth in wounds and implants; tests will be taken using e-swabs 2. Adherence to intraoperative infection preventive measures, measured using a pretested observational tool during 30 full-length procedures and including: 2.1. Body temperature; measured using thermistor catheter 2.2. Door openings; number per hour 2.3. Timing of antibiotics; minutes between the end of infusion and surgical start 2.4. Skin decolonization according to guidelines; yes/no 2.5. Aseptic instrument prep	—

Measure

Time frame

1. Risk factors for PSII will be explored by collecting patient-related data perioperatively. The variables included are: 1.1. Age, years 1.2. Sex, male/female 1.3. ASA classification score (I-IV) 1.4. Body mass index 1.5. Comorbidities 1.6. Nicotine use, yes/no 1.7. Immunosuppressing treatment 1.8. Alcohol use/how many glasses of wine/week/month 1.9. Spinal diagnosis 1.10. Surgical levels involved 1.11. Type of implants used 1.12. Intraoperative bleeding, measured in ml 1.13. Length of surgery, measured in minutes 1.14. Hospital length of stay, measured in days 1.15. Pressure wounds, measured using the Norton scale 1.16. Post-operative wound infection and other hospital-acquired infections, yes/no 1.17. Prophylactic antibiotics, dose and type and serum concentration 1.18. Serum Albumin - venous blood sample 1.19. Serum-C-reactive protein - venous blood sample 1.20. Hba1C - venous blood sample 1.21. Plasma - glucose 1.22. Bacterial growth on skin and nasale; test will be taken using e-swabs and cultured on standard media 1.23. Bacterial growth in wounds and implants; tests will be taken using e-swabs 2. Adherence to intraoperative infection preventive measures, measured using a pretested observational tool during 30 full-length procedures and including: 2.1. Body temperature; measured using thermistor catheter 2.2. Door openings; number per hour 2.3. Timing of antibiotics; minutes between the end of infusion and surgical start 2.4. Skin decolonization according to guidelines; yes/no 2.5. Aseptic instrument prep

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Countries

Sweden

Contacts

Public ContactAnnette Erichsen

annette.erichsen@gu.se+46 (0)737250458

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026