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

NCT01458223 | Completed Phase 4

• 1 other identifier: 17846
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Infection

Keywords

spine surgery; postoperative infection; postoperative antibiotics

Outcome Measures

Primary Outcomes (1)

• Infection Rate

  complicated wound infection requiring surgical irrigation and debridement

  one year

Study Arms (2)

Control

ACTIVE COMPARATOR

24 hours post-operative antibiotics

Drug: Antibiotic

experimental

EXPERIMENTAL

72 hours of post-operative antibiotics

Drug: Antibiotic

Interventions

Antibiotic DRUG

Ancef or Vancomycin

Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The London Spine Centre: lead

Study Sites (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CA (1)