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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891486
• Other study ID #: 20110185
• Status: Completed
• Phase: N/A
• First received: September 1, 2016
• Last updated: February 7, 2017
• Start date: June 2011
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a chart review study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6959
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Spinal surgery
Elective spinal surgery performed

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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