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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891486
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Allan D. Levi, MD, PhD, University of Miami

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.

Condition or disease Intervention/treatment
Infection Procedure: Spinal surgery

Detailed Description:
This is a chart review study.

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Study Type : Observational
Actual Enrollment : 6959 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study
Study Start Date : June 2011
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Incidence of surgical site infection
The number of spinal surgery patients with surgical site infections.
Procedure: Spinal surgery
Elective spinal surgery performed




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years of age or older undergoing a spinal operation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891486


Locations
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United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
University of Miami Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Allan D Levi, MD, PhD University of Miami
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Responsible Party: Allan D. Levi, MD, PhD, Professor and Chairman of Neurological Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT02891486    
Other Study ID Numbers: 20110185
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Allan D. Levi, MD, PhD, University of Miami:
spinal surgery, surgical site infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes