Clinical Trial: Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures (Mandibular Fractures, Zygomaticoorbital Fractures, Isolated Orbital Blow-out Fractures and LeFort I/II/III Fractures): 1 Day vs. 5

Brief Summary:

Facial fractures make up a significant proportion of injuries in trauma patients. Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today. Chole and his team could show that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of an postoperative infection. Up to date there is no standard to support the administration of antibiotics after surgical repair of a facial fracture.

The purpose of this prospective, randomized double-blinded trial is to investigate the utility of antibiotics administered in the postoperative period after surgical revision of facial fractures.

Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective as a long-term administration of 5 days in facial fractures.


Detailed Summary:

Background

While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial its efficacy is well accepted today. Chole et al. showed that the administration of antibiotics reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%.

However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis varies from single-shot up to 7 and even ten days postoperatively.

Antibiotic use is costly and associated with allergic reactions, toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. Additionally some authors assume that a prolonged administration of antibiotics might even increase the risk of infectious complications via superinfection. On the other hand one might risk an increase of postoperative infections with a short term or single shot administration.

In a medline search only few studies could be found which deal with antimicrobial prophylaxis in maxillofacial surgery and in facial trauma surgery in particular.

Articles which advocate a single shot administration contain a very inhomogeneous group of patients. Merten et al. compared a single shot with a 48h regimen. The study included cleft patients, tumor resections, dental surgery, sinus revisions, plastic surgery and trauma. He concluded that a one shot administration of 1500mg cefuroxime is equally effective as a 48h regimen.

The second study which investigated the efficacy of single-dose antibiotic prophylaxis included preprosthetic, plastic, orthognathic, tumor and trauma surgery. Here also single
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Number of patients with infection [ Time Frame: 6 months ]

Infection according to Surgical site infection by CDC


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with infection [ Time Frame: 1 week ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 2 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 4 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 6 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 12 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of days between trauma and first antibiotic administration [ Time Frame: at dismissal from hospital, expected to be after 5 days ]
  • Number of days between trauma and operation [ Time Frame: At dismissal from hospital, expected to be after 5 days ]
  • Location of fracture [ Time Frame: At the end of surgery, expected to be after 90 minutes ]
  • Duration of surgery [ Time Frame: At the end of surgery, expected to be after 90 minutes ]
    Measured in minutes
  • Number of patients with concomitant injuries [ Time Frame: At the end of surgery, expected to be after 90 minutes ]


Original Secondary Outcome:

  • Number of patients with infection [ Time Frame: 1 week ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 2 weeks ]
    Infection (according Surgical site infection by CDC)
  • Number of patients with infection [ Time Frame: 4 weeks ]
    Infection (according Surgical site infection by CDC)
  • Number of patients with infection [ Time Frame: 6 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of patients with infection [ Time Frame: 12 weeks ]
    Infection according to Surgical site infection by CDC
  • Number of days between trauma and first antibiotic administration [ Time Frame: at dismissal from hospital, expected to be after 5 days ]
  • Number of days between trauma and operation [ Time Frame: At dismissal from hospital, expected to be after 5 days ]
  • Location of fracture [ Time Frame: At the end of surgery, expected to be after 90 minutes ]
  • Duration of surgery [ Time Frame: At the end of surgery, expected to be after 90 minutes ]
    Measured in minutes
  • Number of patients with concomitant injuries [ Time Frame: At the end of surgery, expected to be after 90 minutes ]


Information By: University Hospital Inselspital, Berne

Dates:
Date Received: April 20, 2012
Date Started: January 2006
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013