Topical Antibiotic Treatment for Spine Surgical Site Infection

NCT02776774 | Completed Results

• 2 other identifiers: STUDY000017751R21AR068632-01
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection

Keywords

spine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spine surgeons across the United States

You may qualify if:

• Currently practicing spine surgeon, performing at least 5 spine surgeries per year
• Able to provide consent to participate in research
• years of age or older

You may not qualify if:

• Surgeon or other provider that no longer performs spine surgeries

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H.,
• Organization: Surgical Outcomes Research Center - SORCE

amorgan2@uw.edu

206-744-4631

Study Officials

• Amy Cizik, MPH, PhC

  University of Washington

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Outcomes Research Center

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 18, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 13, 2019
• Results First Posted: May 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)