Surgical Wound Infection
Conditions
Keywords
spine
Brief summary
There is considerable interest in using in-wound antibiotics (IWA) to prevent infection after spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited by confounding and bias. This prospective study will enroll spine surgeons across the country to complete a survey about their knowledge, attitudes, and practices for using in-wound antibiotics.
Detailed description
Surgical site infection (SSI) after spine surgery is a devastating complication. Spine SSIs occur in as many as 40,000 people each year, causing considerable disability and resulting in re-operative costs of over $100,000. Even with the use of standard perioperative infection prevention techniques, SSIs occur as often as 3-5% depending on the surveillance technique and time-window used, with widespread variability between practice sites and surgeons. A mainstay of SSI prevention is the timely administration of antibiotics, but one of the limits of intravenous antibiotic prophylaxis is that bone tissue concentrations of antibiotics are lower than blood levels. As a result, there has been increasing interest in the use of in-wound antibiotics (IWA), placed directly on the spine at the completion of surgery. IWAs have been supported by several observational studies with a recent systematic review suggesting an 84% decrease in SSI. However, most of these studies failed to address important confounding in the ways IWA were used and had variable follow-up. The only IWA randomized controlled trial (RCT), albeit underpowered failed to identify a protective effect, leading to uncertainty about the role of IWA. Because of the relative infrequency of SSI, variable windows of follow-up and high rates of confounding in prior studies of IWA a large scale trial of IWA with an appropriate follow-up period is needed to evaluate its effectiveness in spine surgery. Such a trial would be more feasible if randomization occurred at the level of hospital cluster (cRCT), to account for existing variation in practices regarding IWA use, variable rates of SSI, and use of other SSI prevention techniques. Several pilot and feasibility questions need to be addressed before a cRCT of IWA can be proposed. SSI can appear as long as a year after spine surgery and short follow-up time in prior studies may have undercounted events and may have failed to recognize SSIs that may have been potentially delayed in detection because of the IWA. For example, the rationale for surgeon use of IWA, antibiotic type, or dose is unclear, as is whether surgeons use IWA in a similar fashion across patients and sites and if this represents confounding for which researchers must account. It is also unclear if surgeon use of IWAs is related to knowledge about existing data, beliefs and attitudes that may be barriers or enablers to a trial that promotes greater use of IWAs. To address these issues and direct an eventual cRCT, the investigators will perform surveys of spine surgeons assessing knowledge, behaviors and attitudes about IWA.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Currently practicing spine surgeon, performing at least 5 spine surgeries per year * Able to provide consent to participate in research * 18 years of age or older
Exclusion criteria
* Surgeon or other provider that no longer performs spine surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery | Baseline | The investigators will compare answers to survey questions about knowledge of IWA among a diverse surgeon population to assess the feasibility of a future RCT and need for additional evidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Baseline | The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intra-wound Antibiotics (IWA) Knowledge and Use Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons. | 91 |
| Total | 91 |
Baseline characteristics
| Characteristic | — | Intra-wound Antibiotics (IWA) Knowledge and Use |
|---|---|---|
| Age, Customized | — Participants | — |
| Completed a clinical fellowship Currently in fellowship | — | 3 Participants |
| Completed a clinical fellowship Missing | — | 3 Participants |
| Completed a clinical fellowship No | — | 6 Participants |
| Completed a clinical fellowship Yes | — | 79 Participants |
| Do you think a randomized trial on the use of IWA is needed? Missing | — | 1 Participants |
| Do you think a randomized trial on the use of IWA is needed? No | — | 19 Participants |
| Do you think a randomized trial on the use of IWA is needed? Yes | — | 71 Participants |
| Do you use IWA in spine procedures for: All patients | — | 14 Participants |
| Do you use IWA in spine procedures for: Missing | — | 1 Participants |
| Do you use IWA in spine procedures for: No patients | — | 2 Participants |
| Do you use IWA in spine procedures for: Some patients | — | 74 Participants |
| Opinion: Do IWA reduce the risk of infection by: About half | — | 20 Participants |
| Opinion: Do IWA reduce the risk of infection by: Don't know | — | 20 Participants |
| Opinion: Do IWA reduce the risk of infection by: Less than half | — | 16 Participants |
| Opinion: Do IWA reduce the risk of infection by: Missing | — | 1 Participants |
| Opinion: Do IWA reduce the risk of infection by: More than half | — | 31 Participants |
| Opinion: Do IWA reduce the risk of infection by: No benefit | — | 3 Participants |
| Opinion: How often should IWA for spine procedures be used in practice? Don't know | — | 9 Participants |
| Opinion: How often should IWA for spine procedures be used in practice? Missing | — | 1 Participants |
| Opinion: How often should IWA for spine procedures be used in practice? Never | — | 3 Participants |
| Opinion: How often should IWA for spine procedures be used in practice? Routinely (75-100% of the time) | — | 29 Participants |
| Opinion: How often should IWA for spine procedures be used in practice? Selectively (<75% of the time) | — | 49 Participants |
| Opinion: Is IWA use for spine procedures the standard of care? No | — | 46 Participants |
| Opinion: Is IWA use for spine procedures the standard of care? Yes, but only for specific spine procedures | — | 36 Participants |
| Opinion: Is IWA use for spine procedures the standard of care? Yes, for every spine procedure | — | 9 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Don't know | — | 4 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Evidence is non-existent | — | 0 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Missing | — | 2 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Moderate | — | 44 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Strong | — | 15 Participants |
| Opinion: The scientific evidence supporting the use of IWA is: Weak | — | 26 Participants |
| Practice Type Academic Center | — | 42 Participants |
| Practice Type Community Health Center | — | 0 Participants |
| Practice Type Group Practice, 3-5 | — | 4 Participants |
| Practice Type Group Practice, 50+ | — | 5 Participants |
| Practice Type Group Practice, 6-50 | — | 6 Participants |
| Practice Type Missing | — | 3 Participants |
| Practice Type Other | — | 0 Participants |
| Practice Type Physician Owned Group Practice | — | 15 Participants |
| Practice Type Private Hospital | — | 10 Participants |
| Practice Type Solo/2 - Physician Practice | — | 6 Participants |
| Practice Type Veterans Affairs Healthcare System | — | 0 Participants |
| Race and Ethnicity Not Collected | — Participants | — |
| Specialty Missing | — | 3 Participants |
| Specialty Neurological Surgery | — | 18 Participants |
| Specialty Orthopaedic Surgery | — | 69 Participants |
| Specialty Other | — | 1 Participants |
| Surgery Performance Location Academic Center | — | 40 Participants |
| Surgery Performance Location Missing | — | 5 Participants |
| Surgery Performance Location Other | — | 1 Participants |
| Surgery Performance Location Outpatient Surgery Center | — | 0 Participants |
| Surgery Performance Location Private Hospital | — | 37 Participants |
| Surgery Performance Location Public Hospital | — | 8 Participants |
| Surgery Performance Location Veterans Affairs Healthcare System | — | 0 Participants |
| When did you first start using IWA? 1-4 years ago | — | 49 Participants |
| When did you first start using IWA? 5 years ago or more | — | 34 Participants |
| When did you first start using IWA? Less than 1 year ago | — | 5 Participants |
| When did you first start using IWA? Missing | — | 3 Participants |
| Would you be willing to randomize your patients in a clinical trial on the use of IWA? Missing | — | 1 Participants |
| Would you be willing to randomize your patients in a clinical trial on the use of IWA? No | — | 32 Participants |
| Would you be willing to randomize your patients in a clinical trial on the use of IWA? Yes | — | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery
The investigators will compare answers to survey questions about knowledge of IWA among a diverse surgeon population to assess the feasibility of a future RCT and need for additional evidence.
Time frame: Baseline
Population: Spine surgeon opinion regarding if intra-wound antibotic use for spine procedures is the standard of care?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intra-wound Antibiotics (IWA) Knowledge and Use | Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery | Yes, for every spine procedure | 9 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery | Yes, but for only specific spine procedures | 36 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery | No | 46 Participants |
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery
Time frame: Baseline
Population: Spine surgeons
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on no instrumentation procedures | Never | 22 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on no instrumentation procedures | Sometimes | 46 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on no instrumentation procedures | Often | 6 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on no instrumentation procedures | Always | 12 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on no instrumentation procedures | Missing | 5 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on single level instrumentation procedure | Never | 5 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on single level instrumentation procedure | Sometimes | 31 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on single level instrumentation procedure | Often | 13 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on single level instrumentation procedure | Always | 37 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on single level instrumentation procedure | Missing | 5 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on multilevel instrumentation procedures | Never | 0 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on multilevel instrumentation procedures | Sometimes | 19 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on multilevel instrumentation procedures | Often | 18 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on multilevel instrumentation procedures | Always | 49 Participants |
| Intra-wound Antibiotics (IWA) Knowledge and Use | Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery | Use, IWA on multilevel instrumentation procedures | Missing | 5 Participants |