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Dentofacial Deformity | Orthognathic Surgery and Postoperative Antibiotic Use

Dentofacial Deformity research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dentofacial Deformity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Cefazolin, Cephalexin, Clindamycin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cefazolin, Cephalexin, ClindamycinGroup 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

cefazolin, clindamycin, placeboGroup will receive 1 day IV cefazolin, or clindamycin followed by 2 days of oral placebo clindamycin will be used if patient has allergy

Study Status

Unknown status

Start Date: June 2013

Completed Date: October 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Rate of infection

Secondary Outcome: Side effect from antibiotic use

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Atlantic Center for Oral and Maxillofacial Surgery

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01823523

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

Discuss Cephalexin