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The Efficiency of Postoperative Antibiotics in Orthognathic Surgery

NCT02740647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-04-15

No results posted yet for this study

Summary

Orthognathic surgery is the state of art of the maxillofacial surgery, it fix and normalize facial abnormalities and create a harmony between the different tissues compounding the face (bone, soft tissue and dental structures). It is a common procedure and it is done in order to correct a dentofacial and skeletal deformities.

There is an inevitable risk of complications with this type of surgery. While postoperative infections are the most common complication (2% to 33.4%).

preoperative administration of antibiotics have been proven to be effective in reducing the postoperative infection rate, while, the quality of the currently available literature in prescribing continues postoperative antibiotics is questionable and there is still no consensus on its efficacy.

Unwise administration of antibiotics may cause several unwanted side effects such as gastrointestinal symptoms, allergy reactions, high costs, etc… while the most worrisome side effect is a bacterial resentence.

The objective of this study is to investigate the efficacy of postoperative antibiotics. And will try to state a consensus in prescribing postoperative antibiotics. By conducting a prospective, randomized, double-blind, placebo-controlled study, that will explore and analyze the efficacy of postoperative administration of Amoxicillin Clavulanate versus placebo in reducing the rate of postoperative infections in 60 healthy patients.

Conditions

  • Asymptomatic Diseases

Interventions

DRUG

Amoxicillin Clavulanate

getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery

DRUG

Placebo

50 ml of 0.9% sodium chloride three times a day

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2017-03-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740647 on ClinicalTrials.gov