Asymptomatic DiseasesNCT02740647
The Efficiency of Postoperative Antibiotics in Orthognathic Surgery
A study testing Amoxicillin Clavulanate in people with Asymptomatic Diseases, run by The Baruch Padeh Medical Center, Poriya.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Diseases
- What is being tested?
- Amoxicillin Clavulanate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 18> 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.
Trial locations and contacts
No sites are listed yet.
Yasmine Ghantous, DMD, Msc contact
Aviva peleg, Phd contact
About this study
Official title: The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
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%).
Read more
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.
Read the detailed description
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.
This study is a prospective, randomized, double-blind, placebo-controlled study that will investigate the efficacy of postoperative antibiotics. And will try to state a consensus in prescribing postoperative antibiotics.
Objectives and Goals of the study:
The main goal of the present study is to evaluate the efficacy of post operative antibiotics in decreasing the rate of postoperative infections in orthognathic surgery.
Secondary objectives are to state and formulate a consensus in prescribing postoperative antibiotics.
Study Design:
The current study is a prospective, double blind, randomized, placebo control, clinical trial.
The impact of post-operative antibiotics in prevention early surgery related infections will be investigated. The potential benefit of the study lies particular in reducing the various side effects of unwise administration of antibiotics, along with the high cost and bacterial resistant resulted from antibiotics overuse.
The study subjects will be allocated by the investigator into two study groups through the use of randomization. The Intervention group will be getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery; while the Control group will be getting intra-venous Placebo for 5 days.
As described above, 50 patients will participate in this study, an important prerequisite for this study is a completely healthy patients. Then the patients will be allocated randomly into two subgroups: intervention group and control group, as mentioned before.
- Conditions
- Asymptomatic Diseases
- Being tested
- Amoxicillin Clavulanate, Placebo
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin ClavulanateDrug
Also called Augmantin
getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery
PlaceboDrug
50 ml of 0.9% sodium chloride three times a day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will be getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative infection in all patients(50 patients)
the post operative infection will be evaluated using blood tests ( CRP, and WBC)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasmen Ghantous, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740647
- Sponsor's protocol ID
- 0077-14.CTIL
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02740647
- Acronym / sponsor ID
- 0077-14.CTIL
- Conditions
- Asymptomatic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Apr 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
This study is a prospective, randomized, double-blind, placebo-controlled study that will investigate the efficacy of postoperative antibiotics. And will try to state a consensus in prescribing postoperative antibiotics.
Objectives and Goals of the study:
The main goal of the present study is to evaluate the efficacy of post operative antibiotics in decreasing the rate of postoperative infections in orthognathic surgery.
Secondary objectives are to state and formulate a consensus in prescribing postoperative antibiotics.
Study Design:
The current study is a prospective, double blind, randomized, placebo control, clinical trial.
The impact of post-operative antibiotics in prevention early surgery related infections will be investigated. The potential benefit of the study lies particular in reducing the various side effects of unwise administration of antibiotics, along with the high cost and bacterial resistant resulted from antibiotics overuse.
The study subjects will be allocated by the investigator into two study groups through the use of randomization. The Intervention group will be getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery; while the Control group will be getting intra-venous Placebo for 5 days.
As described above, 50 patients will participate in this study, an important prerequisite for this study is a completely healthy patients. Then the patients will be allocated randomly into two subgroups: intervention group and control group, as mentioned before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Amoxicillin ClavulanateIntervention group will be getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery. |
| Control group | Placebo comparator | Drug: Placebothe Control group will be getting intra-venous Placebo (0.9% 50 ml of sodium chloride) for 5 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- 18> 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin ClavulanateAlso: Augmantingetting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery | Drug | Intervention group |
| Placebo50 ml of 0.9% sodium chloride three times a day | Drug | Control group |
Primary outcome
post operative infection in all patients(50 patients)
Time frame: three months
the post operative infection will be evaluated using blood tests ( CRP, and WBC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmine Ghantous, DMD, Msc contact
Aviva peleg, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin Clavulanate in people with Asymptomatic Diseases, run by The Baruch Padeh Medical Center, Poriya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Ghantous, DMD, Msc (yasmen.ghantous@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative infection in all patients(50 patients) (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.