Topical Antibiotic Treatment for Spine Surgical Site Infection

NCT ID: NCT02776774

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-08-31

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.

Conditions

Surgical Wound Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

David Flum

Director, Surgical Outcomes Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Cizik, MPH, PhC

Role: STUDY_DIRECTOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R21AR068632-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001775

Identifier Type: -

Identifier Source: org_study_id