Post-operative infections following spinal implant surgery; incidence and risk factors
| ISRCTN | ISRCTN75456114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75456114 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Sahlgrenska University Hospital |
| Funders | Västra Götalandsregionen, Patientförsäkringen LÖF, Neubergs stiftelse |
- Submission date
- 02/11/2023
- Registration date
- 08/11/2023
- Last edited
- 07/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The number of spinal surgeries has increased significantly during the last 10 years. There are important benefits of instrumented spinal surgery such as prevention of neurological deficits, pain relief, improved physical function, quality of life and patient satisfaction. Unfortunately, these benefits are to some degree negatively balanced by re-operations needed due to post-operative infections. A postoperative wound infection is associated with increased patient suffering, illness, side effects of antimicrobial treatment, vacuum-assisted wound therapy as well as increased risk of destabilization of the spine, pain and disability. The high dose and long course of resistance-driving antibiotics often used in the treatment of implant infections contribute to the overall burden of hard-to-treat microbes. Thus, the overarching and long-term aim of this study is to generate the necessary knowledge needed to reduce the rate of infections and subsequent reoperations in patients undergoing spinal surgery with implants.
Who can participate?
Patients at the study hospital undergoing primary spinal implant surgery from the age of 10 years
What does the study involve?
This is an observational study meaning that there will be no changes in standard care. The difference from standard care involves the collection of patient-related data and the sample of bacteria from the nose, skin and surgical wound as well as blood samples. The data will be used for understanding the most important risk factors associated with a post-operative infection.
What are the possible benefits and risks of participating?
There are no risks or benefits associated with participating.
Where is the study run from?
Sahlgrenska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2022 to December 2025
Who is funding the study?
1. Västra Götalandsregionen (Sweden)
2. Patientförsäkringen LÖF (Sweden)
3. Neubergs stiftelse (Sweden)
Who is the main contact?
Dr Annette Erichsen, annette.erichsen@gu
Contact information
Public, Scientific, Principal investigator
Sahlgrenska University Hospital, Department of Orthopedic research
Göteborgsvägen 31
Mölndal
431 30
Sweden
 ORCID ID |
0000-0002-4785-8544 |
|---|---|
| Phone | +46 (0)737250458 |
| annette.erichsen@gu.se |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Perispinal implant infections; incidence, risk factors, surgical site colonization and its relation to systemic antibiotic prophylaxis |
| Study acronym | SafeSpine |
| Study objectives | The overarching and long-term goal of the project is to generate the necessary knowledge needed to reduce the rate of infections and subsequent reoperations in patients undergoing spinal surgery with implants. Aims: 1. To determine the centre-specific incidence of early and late infections at Sahlgrenska University Hospital in patients undergoing spinal implant surgery 2. To evaluate risk factors for early and late perispinal implant infections (PSII) 3. To trace common opportunistic skin and nasal bacteria and determine minimum inhibitory concentrations (MIC) of prophylactic systemic antimicrobials in causative bacteria in surgical and to evaluate the relationship between: 3.1. Plasma concentrations of prophylactic antibiotics and PSII 3.2. Prophylactic antimicrobial MICs in causative bacteria for PSII 3.3. Nasal colonization of Staphylococcus aureus (S. aureus) and PSII 3.4. Inadequate incisional area decolonization and development of (early/late) PSII 3.5. Index surgery skin/implant colonizers and pathogen concordance 4. To assess how infection prevention measures are used perioperatively |
| Ethics approval(s) |
Approved 09/03/2023, The Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: Dnr 2023-00057-01 |
| Health condition(s) or problem(s) studied | Peri-spinal implant infections |
| Intervention | 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 e-swabs will be used to collect microorganisms in the wound and on implants. 2. During surgery venous blood will be drawn at the time of incision, after 2 hours of surgery and before wound closure 3. Patients will be contacted for follow-up at 10 days, 3 months, 6 months and 1 year after index surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Risk factors for PSII will be explored by collecting patient-related data perioperatively. The variables included are: |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Key inclusion criteria | 1. Patients undergoing spinal implant surgery at the study hospital 2. Primary surgery for the planned spinal surgical level |
| Key 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 |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Gotheburg
413 45
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/11/2023: Study's existence confirmed by The Swedish Ethical Review Authority.
