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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by The London Spine Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Bailey, The London Spine Centre
ClinicalTrials.gov Identifier:
NCT01458223
First received: October 20, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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 Intervention Phase
Postoperative Infection
Drug: Antibiotic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by The London Spine Centre:

Primary Outcome Measures:
  • Infection Rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    complicated wound infection requiring surgical irrigation and debridement


Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458223

Contacts
Contact: Jennifer Fleming, Phd 519-685-8500 ext 53062 jfleming@uwo.ca

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

No publications provided

Responsible Party: Dr. Christopher Bailey, Principal Investigator, The London Spine Centre
ClinicalTrials.gov Identifier: NCT01458223     History of Changes
Other Study ID Numbers: 17846
Study First Received: October 20, 2011
Last Updated: October 20, 2011
Health Authority: Canada: Ethics review board

Keywords provided by The London Spine Centre:
spine surgery
postoperative infection
postoperative antibiotics

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 27, 2014