Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery
1 other identifier
observational
6,959
1 country
2
Brief Summary
Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine services at two facilities on an academic campus. The investigators will collect the data of those patients who develop post-surgical infections. This data will then be analyzed and compared to published data from other studies. The aim of this investigation is to passively collect this infection data, which may ultimately provide needed baseline incidence rates using current and standard protocols.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 9, 2017
February 1, 2017
5.7 years
September 1, 2016
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who develop a surgical site infection (SSI)
Spinal reoperation at the same surgical location for incision, debridement and irrigation
90 days following surgery
Study Arms (1)
Incidence of surgical site infection
The number of spinal surgery patients with surgical site infections.
Interventions
Eligibility Criteria
Patients 18 years of age or older undergoing a spinal operation.
You may qualify if:
- years of age or older
- Patients undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who develop post-operative wound infections within 90 days of surgery
You may not qualify if:
- Patients younger than 18 years of age
- Patients who are not undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who do not develop post-operative wound infections within 90 days of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan D Levi, MD, PhD
University of Miami
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chairman of Neurological Surgery
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 7, 2016
Study Start
June 1, 2011
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 9, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share