The Efficiency of Postoperative Antibiotics in Orthognathic Surgery

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Baruch Padeh Medical Center, Poriya
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

1. Healthy Patients

2. >=18 of age

3. If female, is neither pregnant nor lactating

4. Hemoglobin: >10.5 gm/dl, WBC> 4000mm3, platelets>140.00/mm3

5. Negative to allergic reaction to penicillin (Amoxicillin Clavulanate)

6. Negative to allergic reaction to Natural Rubber Latex

7. 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

8. Able to provide informed consent

9. Must have normal immune function

Exclusion Criteria:

1. 18> years of age.

2. Any acute or chronic viral, bacterial, immune or other disease in a state usually associated with abnormal cellular immunity (HIV, hepatitis, lung disease).

3. History of allergic reactions.