The Efficiency of Postoperative Antibiotics in Orthognathic Surgery

NCT02740647 | Unknown DMC

• 1 other identifier: 0077-14.CTIL
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• post operative infection in all patients(50 patients)

  the post operative infection will be evaluated using blood tests ( CRP, and WBC)

  three months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group will be getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery.

Drug: Amoxicillin Clavulanate

Control group

PLACEBO COMPARATOR

the Control group will be getting intra-venous Placebo (0.9% 50 ml of sodium chloride) for 5 days.

Drug: Placebo

Interventions

Amoxicillin Clavulanate DRUG

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

Also known as: Augmantin

Intervention group

Placebo DRUG

50 ml of 0.9% sodium chloride three times a day

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Patients
• \>=18 of age
• If female, is neither pregnant nor lactating
• Hemoglobin: \>10.5 gm/dl, WBC\> 4000mm3, platelets\>140.00/mm3
• Negative to allergic reaction to penicillin (Amoxicillin Clavulanate)
• Negative to allergic reaction to Natural Rubber Latex
• No immune depressive drugs, e.g. / corticosteroids, cyclosporine, methotrexate, or anti cancer agents, in past one year. Subjects on topical corticosteroids to treat dermatological conditions covering not more than 5% of body surface area are considered eligible
• Able to provide informed consent
• Must have normal immune function

You may not qualify if:

• \> years of age.
• Any acute or chronic viral, bacterial, immune or other disease in a state usually associated with abnormal cellular immunity (HIV, hepatitis, lung disease).
• History of allergic reactions.

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Yasmine Ghantous, DMD, Msc

CONTACT

yasmen.ghantous@gmail.com

Aviva peleg, Phd

CONTACT

Apeleg@poria.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 15, 2016

Record last verified: 2016-04