- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776774
Topical Antibiotic Treatment for Spine Surgical Site Infection
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Time Frame: Baseline
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The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amy Cizik, MPH, PhC, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001775
- 1R21AR068632-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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