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The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain (PARISS)

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ClinicalTrials.gov Identifier: NCT01458223
Recruitment Status : Recruiting
First Posted : October 24, 2011
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Post-operative antibiotics for infection prophylaxis are routinely given to most surgical patients, and for orthopaedic surgery patients, the standard of care is treatment for 24 hours following any elective procedure (1). The most concerning risk for insufficient antibiotic coverage in the post-operative period is the development of a complicated infection requiring irrigation and debridement or revision surgery. Moreover, recovery from surgery is usually delayed in patients that have postoperative wound infections leading to increased resource utilization and increased economic cost for the health care system. It is clear that prophylactic antibiotic therapy is necessary in the immediate post-operative period, but the length required continues to be debated.

Orthopaedic patients undergoing elective spine surgeries often require the placement of a hemovac drain which applies gentle suction to remove excess fluid/blood and to promote healing. Wound drains, however, may also increase the risk of post-operative infection because they expose the "clean" interior aspect of the wound to the "dirty" exterior area around the wound. Given this additional focus of infection, it is unknown whether prolonged antibiotic therapy post-operatively is needed to decrease the rate of infection in this population (2,3). There is sparse literature evaluating the effectiveness of prolonged antibiotic therapy in decreasing complicated post-operative infection requiring irrigation and debridement in this population (1,4). To our knowledge, there are no recent studies comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after removal of the drain. In fact, a recent evidence-based review of the literature by the North American Spine Society highlighted the need for research in this area (5).

The proposed study will compare two patient populations who will receive various lengths of post-operative antibiotics. One will receive only 24 hours worth, and the other will receive antibiotics for 72 hours after surgery and the rate of complicated infection compared between the two.

The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24 hours immediately post-operatively is sufficient for all elective spine patients undergoing posterior spine procedures requiring the placement of a hemovac drain.

Condition or disease Intervention/treatment Phase
Postoperative Infection Drug: Antibiotic Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1066 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain
Study Start Date : October 2011
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Control
24 hours post-operative antibiotics
Drug: Antibiotic
Ancef or Vancomycin
Experimental: experimental
72 hours of post-operative antibiotics
Drug: Antibiotic
Ancef or Vancomycin

Outcome Measures

Primary Outcome Measures :
  1. Infection Rate [ Time Frame: one year ]
    complicated wound infection requiring surgical irrigation and debridement

Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 16 and older
  • Require spine surgery for posterior lumbar decompressions, posterior thoracic decompressions, posterior cervical decompressions, posterior lumbar fusions, posterior thoracic fusions, posterior cervical fusions
  • English speaking and able to understand and provide informed consent

Exclusion Criteria:

  • Known hypersensitivity to antibiotics
  • Severe renal function impairments
  • Antibiotic therapy for concomitant infection at the time of surgery
  • Spine patients not requiring the insertion of a hemovac drain
  • Pregnant
  • Concomitant steroid therapy
  • Permanent residence more than a 5 hour driving distance away from Hospital
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458223

Contact: Jennifer Urquhart, Phd 519-685-8500 ext 53062 jennifer.urquhart@lhsc.on.ca

Canada, Ontario
Victoria Hospital, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
The London Spine Centre
More Information

Responsible Party: Dr. Christopher Bailey, Principal Investigator, The London Spine Centre
ClinicalTrials.gov Identifier: NCT01458223     History of Changes
Other Study ID Numbers: 17846
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Dr. Christopher Bailey, The London Spine Centre:
spine surgery
postoperative infection
postoperative antibiotics

Additional relevant MeSH terms:
Communicable Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents