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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT02891486
• Collaborator: (none)
• Enrollment: 6,959
• Locations: 2
• Duration (Months): 68.1
• Patients Per Site: 3479.5
• Patients Per Site Per Month: 51.1

Study Details

Study Description

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	Phase
Infection	Procedure: Spinal surgery

Detailed Description

This is a chart review study.

Study Design

• 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: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Incidence of surgical site infection The number of spinal surgery patients with surgical site infections.	Procedure: Spinal surgery; Elective spinal surgery performed

Outcome Measures

Primary Outcome Measures

1. Number of patients who develop a surgical site infection (SSI) [90 days following surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Memorial Hospital	Miami	Florida	United States	33136
2	University of Miami Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 7, 2016
• Last Update Posted: Feb 9, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Allan D. Levi, MD, PhD, Professor and Chairman of Neurological Surgery, University of Miami: spinal surgery, surgical site infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound

Study Results

No Results Posted as of Feb 9, 2017