Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Spinal Deformity Spinal Degeneration Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Hospital for Joint Diseases

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic Protocol

Other

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

Primary outcomes

Incidence of Infection

Time frame: for one year after surgery

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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: May 31, 2012
Registry last updated: Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed