Facial FracturesPhase 2EAPRTSNCT01993134
Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery
A Phase 2 study testing Cefazolin and Cefazolin Single Dose in people with Facial Fractures, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Facial Fractures
- What is being tested?
- Cefazolin and Cefazolin Single Dose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 2
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both genders
- ASA I, II, III
- have facial fractures, that request surgical treatement, and whitout infection
Who cannot join
- Patients with pan-facial fractures
- Or requiring surgery longer than six hours
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital
Natal, Rio Grande do Norte, 59012-300
Giordano Campos, DDS, +558491015536, giordano_campos@hotmail.com
Adriano Germano, PhD
About this study
Official title: Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery.
The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.
Read the detailed description
The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.This clinical study was prospective, randomized and controlled. Patients underwent surgery for facial fracture reduction and fixation under general anesthetic. Prior to surgery, patients were randomly divided into two groups. Group 1 patients each received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period. Group II patients received the same dose prior to the operation but in the post-operative period they also received 4 additional 1 g doses of Cefazolin intravenously, completing a 24 period of antibiotic prophylaxis. In the case of operations that lasted for more than 4 hours, an additional 1g dose was given.
The surgical operations involved intra and extra-oral interventions and when required internal rigid fixation was undertaken using titanium plates and screws. Patients were given advice on oral hygiene procedures to be followed in the post-operative period that included chlorhexidine (0.12%) oral rinses and care to be taken with the surgical wounds.
Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.
Descriptive analysis was made of the independent variables, namely, age, sex, presence of systemic diseases, trauma cause, drug use (tobacco, alcohol, marijuana, crack, cocaine , etc.), the time lapse between the trauma event and the surgical operation, length of the operation, and the measures adopted when infections were detected.
- Conditions
- Facial Fractures
- Being tested
- Cefazolin, Cefazolin Single Dose
- Keywords
- Postoperative infection, Antibiotic prophylaxis, Cefazolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinProcedure or surgery
Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.
Cefazolin Single DoseProcedure or surgery
Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Experimental | 2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h. Receives: Procedure: Cefazolin |
| Cefazolin Single Dose | Active comparator | 2g of Cefazolin, 20minutes before sugery. After surgery, no drugs. Receives: Procedure: Cefazolin Single Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of postoperative infection
Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial FracturesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giordano Bruno Paiva Campos, Universidade Federal do Rio Grande do Norte
- Investigators
- Adriano Germano, PhD, Study chair, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993134
- Sponsor's protocol ID
- ATB-001
- Acronym
- EAPRTS
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery.
- ClinicalTrials.gov ID
- NCT01993134
- Acronym / sponsor ID
- EAPRTS / ATB-001
- Conditions
- Facial Fractures
- Keywords
- Postoperative infection, Antibiotic prophylaxis, Cefazolin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Nov 2013 (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.
The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.
Detailed description
The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.This clinical study was prospective, randomized and controlled. Patients underwent surgery for facial fracture reduction and fixation under general anesthetic. Prior to surgery, patients were randomly divided into two groups. Group 1 patients each received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period. Group II patients received the same dose prior to the operation but in the post-operative period they also received 4 additional 1 g doses of Cefazolin intravenously, completing a 24 period of antibiotic prophylaxis. In the case of operations that lasted for more than 4 hours, an additional 1g dose was given.
The surgical operations involved intra and extra-oral interventions and when required internal rigid fixation was undertaken using titanium plates and screws. Patients were given advice on oral hygiene procedures to be followed in the post-operative period that included chlorhexidine (0.12%) oral rinses and care to be taken with the surgical wounds.
Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.
Descriptive analysis was made of the independent variables, namely, age, sex, presence of systemic diseases, trauma cause, drug use (tobacco, alcohol, marijuana, crack, cocaine , etc.), the time lapse between the trauma event and the surgical operation, length of the operation, and the measures adopted when infections were detected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Experimental | Procedure: Cefazolin2g of Cefazolin, 20minutes before sugery. After surgery, 1g of cefazolin 06/06h. |
| Cefazolin Single Dose | Active comparator | Procedure: Cefazolin Single Dose2g of Cefazolin, 20minutes before sugery. After surgery, no drugs. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both genders
- ASA I, II, III
- have facial fractures, that request surgical treatement, and whitout infection
Key exclusion criteria (2 listed)
- Patients with pan-facial fractures
- Or requiring surgery longer than six hours
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 |
|---|---|---|
| CefazolinCefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin. | Procedure or surgery | Cefazolin |
| Cefazolin Single DosePatients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period | Procedure or surgery | Cefazolin Single Dose |
Primary outcome
Reduction of postoperative infection
Time frame: 45 days
Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital
Natal, Brazil
Adriano Germano, PhD study chair
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefazolin and Cefazolin Single Dose in people with Facial Fractures, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 3 inclusion and 2 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of postoperative infection (time frame: 45 days). 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 25 Nov 2013.