The grades of recommendations (A-C, I) and levels of evidence (I-V) are defined at the end of the "Major Recommendations" field.
Recommendations Regarding Antibiotic Prophylaxis in Spine Surgery
Efficacy
For patients undergoing spine surgery, does antibiotic prophylaxis result in decreased infection rates compared to patients who do not receive prophylaxis?
Patients undergoing spine surgery should receive preoperative prophylactic antibiotics.
Grade of Recommendation: B
For patients undergoing spine surgery without spinal implants, does antibiotic prophylaxis result in decreased infection rates as compared to patients who do not receive prophylaxis?
Prophylactic antibiotics are recommended to decrease the rate of spinal infections following uninstrumented lumbar spinal surgery.
Grade of Recommendation: B
For patients undergoing spine surgery with spinal implants, does antibiotic prophylaxis result in decreased infection rates as compared to patients who do not receive prophylaxis?
Prophylactic antibiotics are recommended to decrease the rate of infections following instrumented spine fusion.
Grade of Recommendation: C
Protocol
For patients receiving antibiotic prophylaxis prior to spine surgery, what are the recommended drugs, their dosages and time of administration resulting in decreased postoperative infection rates?
Patients undergoing spine surgery should receive preoperative prophylactic antibiotics to decrease infection rates. The superiority of one agent or schedule over any other has not been clearly demonstrated.
Grade of Recommendation: B
For patients receiving antibiotic prophylaxis prior to spine surgery without spinal implants, what are the recommended drugs, their dosages and time of administration resulting in decreased postoperative infections rates?
Review of the current literature does not allow recommendation of one specific antibiotic protocol or dosing regimen over another in the prevention of postoperative infections following uninstrumented spinal surgery.
Level of Evidence: II
For patients receiving antibiotic prophylaxis prior to spine surgery with spinal implants, what are the recommended drugs, their dosages and time of administration resulting in decreased postoperative infections rates?
In patients with risk factors for polymicrobial infection, it is recommended that appropriate broad spectrum antibiotics be considered when instrumented fusion is performed.
Grade of Recommendation: C
Redosing
For patients receiving antibiotic prophylaxis prior to spine surgery, what are the intraoperative redosing recommendations for the recommended drugs (including dosages and time of administration) resulting in decreased postoperative infection rates?
Dosing regimens do not appear to affect infection rates. Although no study has shown any significant advantage to intraoperative redosing compared with a single dose, specific clinical situations may dictate additional doses (e.g., length of surgery, comorbidities).
Level of Evidence: IV
Discontinuation
For patients receiving antibiotic prophylaxis prior to spine surgery, does discontinuation of prophylaxis at 24 hours result in decreased or increased postoperative infection rates as compared to longer periods of administration?
A comprehensive review of the spine literature did not yield evidence to address the question related to the effect on postoperative infection rates of discontinuation of prophylaxis at 24 hours compared with longer periods of administration.
Wound Drains
For patients receiving antibiotic prophylaxis prior to spine surgery and who receive placement of wound drains at wound closure, does discontinuation of prophylaxis at 24 hours result in decreased or increased postoperative infection rates as compared to discontinuation of antibiotics at time of drain removal?
A comprehensive review of the literature did not yield evidence to address the question related to the effect on postoperative infection rates of the duration of prophylaxis in the presence of a wound drain.
The use of drains is not recommended as a means to reduce infection rates following single level surgical procedures.
Grade of Recommendation: I (Insufficient Evidence)
Body Habitus
For patients receiving antibiotic prophylaxis prior to spine surgery, should the recommended protocol differ based upon body habitus (e.g., body mass index)?
Obese patients are at higher risk for postoperative infection, when given a standardized dose of antibiotic prophylaxis. In spite of this conclusion, the literature search did not yield sufficient evidence to recommend any specific modifications to antibiotic protocols for this specific population.
Level of Evidence: III
Comorbidities
For patients receiving antibiotic prophylaxis prior to spine surgery, do comorbidities (other than obesity) such as diabetes, smoking, nutritional depletion and immunodeficiencies alter the recommendations for antibiotic prophylaxis?
Based on the literature reviewed to address this question, information was only available on patients with diabetes, older age or instrumentation. While this information suggests that these three groups are at higher risk for postoperative infection when given a standardized dose of antibiotic prophylaxis, the literature search did not yield sufficient evidence to recommend any specific modifications to antibiotic protocols for this specific population.
Level of Evidence: III
Definitions:
Levels of Evidence for Primary Research Question1
Types of Studies |
|
Therapeutic Studies – Investigating the results of treatment |
Prognostic Studies –Investigating the effect of a patient characteristic on the outcome of disease |
Diagnostic Studies –Investigating a diagnostic test |
Economic and Decision Analyses – Developing an economic or decision model |
Level I |
- High quality randomized trial with statistically significant difference or no statistically significant difference but narrow confidence intervals
- Systematic Review2 of Level I RCTs (and study results were homogenou3)
|
- High quality prospective study4 (all patients were enrolled at the same point in their disease with >80% follow-up of enrolled patients)
- Systematic review2 of Level I studies
|
- Testing of previously developed diagnostic criteria on consecutive patients (with universally applied reference "gold" standard)
- Systematic review2 of Level I studies
|
- Sensible costs and alternatives; values obtained from many studies; with multiway sensitivity analyses
- Systematic review2 of Level I studies
|
Level II |
- Lesser quality RCT (e.g., <80% follow-up, no blinding, or improper randomization)
- Prospective4 comparative study5
- Systematic review2 of Level II studies or Level 1 studies with inconsistent results
|
- Retrospective6 study
- Untreated controls from an RCT
- Lesser quality prospective study (e.g., patients enrolled at different points in their disease or <80% follow-up)
- Systematic review2 of Level II studies
|
- Development of diagnostic criteria on consecutive patients (with universally applied reference "gold" standard)
- Systematic review2 of Level II studies
|
- Sensible costs and alternatives; values obtained from limited studies; with multiway sensitivity analyses
- Systematic review2 of Level II studies
|
Level III |
- Case control study7
- Retrospective6 comparative study5
- Systematic review2 of Level III studies
|
|
- Study of nonconsecutive patients; without consistently applied reference "gold" standard
- Systematic review2 of Level III studies
|
- Analyses based on limited alternatives and costs; and poor estimates
- Systematic review2 of Level III studies
|
Level IV |
Case series8 |
Case series |
- Case-control study
- Poor reference standard
|
Analyses with no sensitivity analyses |
Level V |
Expert opinion |
Expert opinion |
Expert opinion |
Expert opinion |
RCT = randomized controlled trial.
- A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
- A combination of results from two or more prior studies.
- Studies provided consistent results.
- Study was started before the first patient enrolled.
- Patients treated one way (e.g., cemented hip arthroplasty) compared with a group of patients treated in another way (e.g., uncemented hip arthroplasty) at the same institution.
- The study was started after the first patient enrolled.
- Patients identified for the study based on their outcome, called "cases"; e.g., failed total arthroplasty, are compared to those who did not have outcome, called "controls"; e.g., successful total hip arthroplasty.
- Patients treated one way with no comparison group of patients treated in another way.
Grades of Recommendation
A: Good evidence (Level I studies with consistent finding) for or against recommending intervention.
B: Fair evidence (Level II or III studies with consistent findings) for or against recommending intervention.
C: Poor quality evidence (Level IV or V studies) for or against recommending intervention.
I: Insufficient or conflicting evidence not allowing a recommendation for or against intervention.