Clinical Trial: The Efficiency of Postoperative Antibiotics in Orthognathic Surgery
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Detailed Summary:
The first Orthographic operation was carried out in 1849, for the correction of malocclusions, in the United States of America. Back then, this surgery was merely a mandibular operation and was called Hullihen's procedure done by general surgeons. However, the first cooperation between surgeons and orthodontists in the evolution of the early orthognathic surgery was cradled in St. Louis by the orthodontist Edward Angle (1898) and the surgeon Vilray Blair (1906). During the 19th orthognathic surgery underwent minor improvements, never the less, not until the beginning of the 1950s, when orthognathic surgery was deemed as a true specialty had its origins, which led to tremendous success all over the world. Nowadays, orthognathic surgery is performed not only for correcting dental and skeletal deformities, but also is conducted as a treatment of various congenital and cranio-facial syndromes, such as Crouzon syndrome, Treacher syndrome and Apert's syndrome.
However, orthognathic surgery is not an innocent procedure, since it contains several complications. Pain, swelling, neurosensory deficits and post operative infections are the most common complications. While postoperative infection is the most common one, with a 2% to 33.4% percentage of occurrences. Postoperative infections increase the mortality rate of orthognathic procedure and may create a challenge for the surgeon and the medical staff, thus, reducing its prevalence is critical issue in defining the success of this unique procedure.
Preoperative prophylaxis has been proven as an efficient in decreasing the rate of postoperative infections in orthognathic surgery.
While the current literature regarding the efficacy of postoperative antibiotics questionable and there is still no consensus on its efficacy.
Sponsor: The Baruch Padeh Medical Center, PoriyaCurrent Primary Outcome: post operative infection in all patients(50 patients) [ Time Frame: three months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Baruch Padeh Medical Center, Poriya
Dates:
Date Received: March 20, 2016
Date Started: April 2016
Date Completion: March 2017
Last Updated: April 14, 2016
Last Verified: April 2016
