Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures
This study is currently recruiting participants.
Verified December 2012 by University Hospital Inselspital, Berne
Sponsor:
University Hospital Inselspital, Berne
Collaborators:
Schweizerische Unfallversicherung SUVA, Switzerland
Mepha Parma AG, Switzerland
GlaxoSmithKline AG, Switzerland
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01583062
First received: April 20, 2012
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
Facial fractures make up a significant proportion of injuries in trauma patients. Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today. Chole and his team could show that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42,2% to 8.9%. However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot 6-7 up to a duration of 7 and even ten days postoperatively 8-10. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance. In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of an postoperative infection. Up to date there is no standard to support the administration of antibiotics after surgical repair of a facial fracture.
The purpose of this prospective, randomized double-blinded trial is to investigate the utility of antibiotics administered in the postoperative period after surgical revision of facial fractures.
Hypothesis: a short-term antibiotic prophylaxis of 1 day postoperatively is equally effective as a long-term administration of 5 days in facial fractures.
| Condition | Intervention | Phase |
|---|---|---|
|
Surgical Wound Infection |
Drug: Amoxicillin/clavulanic acid Drug: Amoxicillin plus placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures (Mandibular Fractures, Zygomaticoorbital Fractures, Isolated Orbital Blow-out Fractures and LeFort I/II/III Fractures): 1 Day vs. 5 Days: a Prospective, Randomized, Double Blind and Placebo Controlled Study (Phase IV) |
Resource links provided by NLM:
Further study details as provided by University Hospital Inselspital, Berne:
Primary Outcome Measures:
- Number of patients with infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
Secondary Outcome Measures:
- Number of patients with infection [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
- Number of patients with infection [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
- Number of patients with infection [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
- Number of patients with infection [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
- Number of patients with infection [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Infection according to Surgical site infection by CDC
- Number of days between trauma and first antibiotic administration [ Time Frame: at dismissal from hospital, expected to be after 5 days ] [ Designated as safety issue: No ]
- Number of days between trauma and operation [ Time Frame: At dismissal from hospital, expected to be after 5 days ] [ Designated as safety issue: No ]
- Location of fracture [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]
- Duration of surgery [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]Measured in minutes
- Number of patients with concomitant injuries [ Time Frame: At the end of surgery, expected to be after 90 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
|
Drug: Amoxicillin/clavulanic acid
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
|
|
Placebo Comparator: 2
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.
|
Drug: Amoxicillin plus placebo
Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Isolated orbital fracture, zygomatic fracture, mandibular fracture, or LeFort I/II/III fracture which requires surgical treatment
- Written informed consent obtained
Exclusion Criteria
- Need of intensive care treatment
- Presence of an acute bacterial infection
- Gunshot wounds
- Pathological fracture
- Skull base fracture with rhinoliquorrhea or intracranial emphysema
- History of malignancy or radiation to the head and neck area
- Known hypersensitivity, allergy to penicillin or other beta-lactam antibiotics
- Reduced body weight (<40kg or BMI<17), severe renal insufficiency (stage 4 according to the Kidney Disease Outcomes Quality Initiative (KDOQI))
- Insufficient patient compliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583062
Contacts
| Contact: Juergen Zix, MD, DMD | ++41 632 4444 | juergen.zix@insel.ch |
Locations
| Switzerland | |
| Dep. of Oral and Maxillofacial Surgery, Bern University Hospital | Recruiting |
| Bern, Switzerland, CH-3011 | |
| Contact: Juergen Zix, MD, DMD ++41 632 4444 juergen.zix@insel.ch | |
| Contact: Olivier Lieger, MD, DMD ++41 76 567 3111 olieger@hotmail.com | |
| Principal Investigator: Olivier Lieger, MD, DMD | |
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Unfallversicherung SUVA, Switzerland
Mepha Parma AG, Switzerland
GlaxoSmithKline AG, Switzerland
Investigators
| Principal Investigator: | Olivier Lieger, MD, DMD | Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland |
| Study Chair: | Tateyuki Iizuka, MD, DDS, PhD | Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland |
More Information
Additional Information:
Publications:
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT01583062 History of Changes |
| Other Study ID Numbers: | 235/04, 1601 |
| Study First Received: | April 20, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Swissmedic |
Keywords provided by University Hospital Inselspital, Berne:
|
Surgical Wound Infection Facial Injuries Orbital Fractures |
Zygomatic Fractures Mandibular Fractures Jaw Injuries |
Additional relevant MeSH terms:
|
Skull Fractures Fractures, Bone Mandibular Fractures Surgical Wound Infection Wound Infection Wounds and Injuries Jaw Fractures Maxillofacial Injuries Facial Injuries Craniocerebral Trauma Infection |
Postoperative Complications Pathologic Processes Amoxicillin Anti-Bacterial Agents Clavulanic Acids Clavulanic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013