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Clinical Trials/NCT02891486
NCT02891486
Completed
Not Applicable

Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study

University of Miami2 sites in 1 country6,959 target enrollmentJune 2011
ConditionsInfection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection
Sponsor
University of Miami
Enrollment
6959
Locations
2
Primary Endpoint
Number of patients who develop a surgical site infection (SSI)
Status
Completed
Last Updated
9 years ago

Overview

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.

Detailed Description

This is a chart review study.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
February 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allan D. Levi, MD, PhD

Professor and Chairman of Neurological Surgery

University of Miami

Eligibility Criteria

Inclusion Criteria

  • 18 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of patients who develop a surgical site infection (SSI)

Time Frame: 90 days following surgery

Spinal reoperation at the same surgical location for incision, debridement and irrigation

Study Sites (2)

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