Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

Surgical Wound Infection Clinical Trial

Official title:

Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608854
• Other study ID #: NYUHJD08139
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: June 8, 2016
• Start date: November 2008
• Est. completion date: April 2012

Study information

• Verified date: June 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.

Description:

Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)

• Must be over the age of 18

• Must consent to randomized postoperative antibiotic treatment

Exclusion Criteria:

• Does not receive a drain at the time of surgery

• Surgery is cancelled

• Infection is present at the time of initial surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Deformity
• Spinal Degeneration
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• Antibiotic Protocol
Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.

Locations

Country	Name	City	State
United States	NYU Hospital for Joint Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Infection	Patients were contacted and their medical records were reviewed for a minimum of one year after surgery in order to determine the incidence of postoperative infection. The Center for Disease Control's definition of surgical site infection was applied in determining infection rates.	for one year after surgery	Yes