Recruiting

Orthognathic Surgery

Sponsor:

Atlantic Center for Oral and Maxillofacial Surgery

Code:

NCT01823523

Conditions

Dentofacial Deformity

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Cefazolin, Cephalexin, Clindamycin

Study Details

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.

Conditions

Dentofacial Deformity

Study ID

NCT01823523

Start date

Jun, 2013

Status verified date

Jan, 2015

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

Interventions

Cefazolin, Cephalexin, Clindamycin

Primary outcome measure

  • Rate of infection [ Time Frame: 4 weeks following surgery ]

Central Contacts and Locations

Locations

Victoria General Hospital

Recruiting

Halifax, Nova Scotia, Canada, B3H 1W2

Contacts

Clayton Davis, DDS

902-473-2070cmd@dal.ca

More Information

Sponsor

Atlantic Center for Oral and Maxillofacial Surgery

Last update posted

Jan 14, 2015

Last verified

Jan, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Center for Oral and Maxillofacial Surgery on 2015-01-14.