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

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

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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Procedure: Spinal surgery

Detailed Description

This is a chart review study.

• Study Type: Observational
• Enrollment (Actual): 6959

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
    • Miami, Florida, United States, 33136
      • University of Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older undergoing a spinal operation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Allan D Levi, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: spinal surgery, surgical site infection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 20110185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO