Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

This study has been terminated.
(Limited number of patients)
Sponsor:
Collaborators:
Schweizerische Unfallversicherung SUVA, Switzerland
Mepha Parma AG, Switzerland
GlaxoSmithKline AG, Switzerland
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01583062
First received: April 20, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Surgical Wound Infection
Drug: Amoxicillin/clavulanic acid
Drug: Amoxicillin plus placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Days: a Prospective, Randomized, Double Blind and Placebo Controlled Study (Phase IV)

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number of patients with infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Infection according to Surgical site infection by CDC


Secondary Outcome Measures:
  • Number of patients with infection [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Infection according to Surgical site infection by CDC

  • Number of patients with infection [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Infection according to Surgical site infection by CDC

  • Number of patients with infection [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Infection according to Surgical site infection by CDC

  • Number of patients with infection [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Infection according to Surgical site infection by CDC

  • Number of patients with infection [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Number of days between trauma and operation [ Time Frame: At dismissal from hospital, expected to be after 5 days ] [ Designated as safety issue: No ]
  • Location of fracture [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]
  • Duration of surgery [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]
    Measured in minutes

  • Number of patients with concomitant injuries [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: January 2006
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
Drug: Amoxicillin/clavulanic acid
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
Placebo Comparator: 2
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.
Drug: Amoxicillin plus placebo
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Isolated orbital fracture, zygomatic fracture, mandibular fracture, or LeFort I/II/III fracture which requires surgical treatment
  • Written informed consent obtained

Exclusion Criteria

  • Need of intensive care treatment
  • Presence of an acute bacterial infection
  • Gunshot wounds
  • Pathological fracture
  • Skull base fracture with rhinoliquorrhea or intracranial emphysema
  • History of malignancy or radiation to the head and neck area
  • Known hypersensitivity, allergy to penicillin or other beta-lactam antibiotics
  • Reduced body weight (<40kg or BMI<17), severe renal insufficiency (stage 4 according to the Kidney Disease Outcomes Quality Initiative (KDOQI))
  • Insufficient patient compliance
  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: NCT01583062

Locations
Switzerland
Dep. of Oral and Maxillofacial Surgery, Bern University Hospital
Bern, Switzerland, CH-3011
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Unfallversicherung SUVA, Switzerland
Mepha Parma AG, Switzerland
GlaxoSmithKline AG, Switzerland
Investigators
Principal Investigator: Olivier Lieger, MD, DMD Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland
Study Chair: Tateyuki Iizuka, MD, DDS, PhD Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland
  More Information

Additional Information:
Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01583062     History of Changes
Other Study ID Numbers: 235/04, 1601
Study First Received: April 20, 2012
Last Updated: July 12, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
Surgical Wound Infection
Facial Injuries
Orbital Fractures
Zygomatic Fractures
Mandibular Fractures
Jaw Injuries

Additional relevant MeSH terms:
Fractures, Bone
Mandibular Fractures
Surgical Wound Infection
Wound Infection
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Skull Fractures
Infection
Postoperative Complications
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014