Clinical Trial: Orthognathic Surgery and Postoperative Antibiotic Use

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Orthognathic Surgery and Postoperative Antibiotic Use

Brief Summary: Currently there is debate in the literature as to the recommended length of postoperative antibiotics in patients undergoing orthognathic surgery. The investigators plan to investigate using a randomized controlled trial the comparison between a 1 day and 3 day regimen of antibiotics and the effects on post operative infection.

Detailed Summary:

Capital Health Research Ethics Board Orthognathic Surgery and Postoperative Antibiotic Use Protocol

Background, Rationale and Statement of Research Question(s):

Surgical site infection is a potential problem with any surgical procedure. Surgical procedures done through the oral cavity are at a higher risk due to the presence of bacterial pathogens. Orthognathic surgery, involves incising through oral mucosa and creating osteotomies in underlying bony structures. Of the potential complications that can arise from this surgery, post operative infection (POI) is the most common. POI can have a significant impact on surgical outcomes and are associated with an increased cost to the health care system. The literature is quite clear on the benefits of presurgical prophylactic antibiotics in reducing the rate of post operative surgical site infections.1 Currently there is conflicting literature as to the recommended length patients should receive antibiotics during the postoperative course, and the majority of studies have small sample sizes.2,3

Orthognathic surgery is considered a clean-contaminated surgery with a suspected POI rate of 10-15%.2 In 1999 Bentley et. al conducted a randomized control trial comparing 1day vs 5day regimen of antibiotics following orthognathic surgery.4 This trial was stopped due to the drastic difference seen between the two groups, 6.7% in the 5 day course compared with 60% seen in the 1 day group.4 This data varies greatly from the rates of infection that the investigators have seen in their department using a 1 day course of antibiotics. Chow et al. in 2007 did a retrospective chart review of complications seen in orthognathic surgery. They found the rate of infection was significantly decreased by continuing antibiotics in the post operative cours
Sponsor: Atlantic Center for Oral and Maxillofacial Surgery

Current Primary Outcome: Rate of infection [ Time Frame: 4 weeks following surgery ]

Investigation of the incidence of post operative infection following surgery in each of the two groups


Original Primary Outcome: Same as current

Current Secondary Outcome: Side effect from antibiotic use [ Time Frame: 4 weeks ]

investigation of the incidence of side effects from an extended antibiotic regimen


Original Secondary Outcome: Same as current

Information By: Atlantic Center for Oral and Maxillofacial Surgery

Dates:
Date Received: March 29, 2013
Date Started: June 2013
Date Completion: October 2015
Last Updated: January 12, 2015
Last Verified: January 2015