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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AR068632-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Spine surgeons across the United States
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| Name | Affiliation | Role |
|---|---|---|
| Amy Cizik, MPH, PhC | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intra-wound Antibiotics (IWA) Knowledge and Use | Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Spine surgeons
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| ID | Title | Description |
|---|---|---|
| BG000 | Intra-wound Antibiotics (IWA) Knowledge and Use | Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age not captured in study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Spine surgeon opinion regarding if intra-wound antibotic use for spine procedures is the "standard of care"? | Posted | Count of Participants | Participants | Baseline |
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Adverse Events not tracked and are inapplicable to this study.
Adverse Events not tracked and are inapplicable to this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intra-wound Antibiotics (IWA) Knowledge and Use | Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons. |
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It is unknown if participants that did not complete the survey would have been willing to participant in RCTs or not, or use IWA or not.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H., | Surgical Outcomes Research Center - SORCE | 206-744-4631 | amorgan2@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2019 | May 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2019 | May 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Count of Participants |
| Participants |
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| Sex: Female, Male | Sex not captured in study | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Completed a clinical fellowship | Count of Participants | Participants |
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| Specialty | Count of Participants | Participants |
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| Practice Type | Count of Participants | Participants |
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| Surgery Performance Location | Count of Participants | Participants |
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| Opinion: Is IWA use for spine procedures the "standard of care"? | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Opinion: How often should IWA for spine procedures be used in practice? | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Opinion: The scientific evidence supporting the use of IWA is: | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Opinion: Do IWA reduce the risk of infection by: | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Do you think a randomized trial on the use of IWA is needed? | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Would you be willing to randomize your patients in a clinical trial on the use of IWA? | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Do you use IWA in spine procedures for: | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| When did you first start using IWA? | There was only one timepoint for this study (baseline). This variable was collected at the single timpoint and is not an outcome measure. | Count of Participants | Participants |
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| Participants |
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| Secondary | 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 | Spine surgeons | Posted | Count of Participants | Participants | Baseline |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Always |
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| Missing |
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| Use, IWA on single level instrumentation procedure |
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| Use, IWA on multilevel instrumentation procedures |
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