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Orthognathic Surgery and Postoperative Antibiotic Use

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ClinicalTrials.gov Identifier: NCT01823523
Recruitment Status : Unknown
Verified January 2015 by Dr. Curtis Gregoire, Atlantic Center for Oral and Maxillofacial Surgery.
Recruitment status was:  Recruiting
First Posted : April 4, 2013
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Curtis Gregoire, Atlantic Center for Oral and Maxillofacial Surgery

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.

Condition or disease Intervention/treatment Phase
Dentofacial Deformity Drug: Cefazolin, Cephalexin, Clindamycin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Orthognathic Surgery and Postoperative Antibiotic Use
Study Start Date : June 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: Cefazolin, Cephalexin, Clindamycin

Group will be receiving 1 day of IV cefazolin or clindamycin followed by 2 days of oral cephalexin or clindamycin

Clindamycin will be used in patients with allergy

Drug: Cefazolin, Cephalexin, Clindamycin
Other Name: Ancef, Keflex, Dalacin C

Placebo Comparator: cefazolin, clindamycin, placebo

Group will receive 1 day IV cefazolin, or clindamycin followed by 2 days of oral placebo

clindamycin will be used if patient has allergy

Drug: Cefazolin, Cephalexin, Clindamycin
Other Name: Ancef, Keflex, Dalacin C




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Side effect from antibiotic use [ Time Frame: 4 weeks ]
    investigation of the incidence of side effects from an extended antibiotic regimen



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • over 16 years old undergoing orthognathic surgery

Exclusion Criteria:

  • Use of antibiotics in last 2 weeks, active oral or odontogenic infection, significant medical condition, immunocompromised

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823523


Locations
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Canada, Nova Scotia
Victoria General Hospital Recruiting
Halifax, Nova Scotia, Canada, B3H 1W2
Contact: Clayton Davis, DDS    902-473-2070    cmd@dal.ca   
Sponsors and Collaborators
Atlantic Center for Oral and Maxillofacial Surgery

Publications:

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Responsible Party: Dr. Curtis Gregoire, Dr. Curtis Gregoire Oral and Maxillofacial Surgeon, Atlantic Center for Oral and Maxillofacial Surgery
ClinicalTrials.gov Identifier: NCT01823523     History of Changes
Other Study ID Numbers: ACOMFS-Orthognathic
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dentofacial Deformities
Congenital Abnormalities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Anti-Bacterial Agents
Cefazolin
Cephalexin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action