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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)

Primary Purpose

Postoperative Infection

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Antibiotic
Antibiotic
Sponsored by
The London Spine Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Infection focused on measuring spine surgery, postoperative infection, postoperative antibiotics

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Victoria Hospital, London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

experimental

Arm Description

24 hours post-operative antibiotics

72 hours of post-operative antibiotics

Outcomes

Primary Outcome Measures

Infection Rate
complicated wound infection requiring surgical irrigation and debridement

Secondary Outcome Measures

Full Information

First Posted
October 20, 2011
Last Updated
August 17, 2018
Sponsor
The London Spine Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01458223
Brief Title
The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain
Acronym
PARISS
Official Title
The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The London Spine Centre

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Infection
Keywords
spine surgery, postoperative infection, postoperative antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
645 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
24 hours post-operative antibiotics
Arm Title
experimental
Arm Type
Experimental
Arm Description
72 hours of post-operative antibiotics
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Ancef or Vancomycin
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Ancef or Vancomycin
Primary Outcome Measure Information:
Title
Infection Rate
Description
complicated wound infection requiring surgical irrigation and debridement
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Victoria Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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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

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