Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures

NCT01583062 | Terminated Phase 4 DMC

• 2 other identifiers: 235/041601
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Wound Infection

Keywords

Surgical Wound Infection; Facial Injuries; Orbital Fractures; Zygomatic Fractures; Mandibular Fractures; Jaw Injuries

Outcome Measures

Primary Outcomes (1)

• Number of patients with infection

  Infection according to Surgical site infection by CDC

  6 months

Secondary Outcomes (10)

• Number of patients with infection

  1 week

• Number of patients with infection

  2 weeks

• Number of patients with infection

  4 weeks

• Number of patients with infection

  6 weeks

• Number of patients with infection

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

Amoxicillin/clavulanic acid DRUG

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.

1

Amoxicillin plus placebo DRUG

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.

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated orbital fracture, zygomatic fracture, mandibular fracture, or LeFort I/II/III fracture which requires surgical treatment
• Written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Schweizerische Unfallversicherung SUVA, Switzerland: collaborator
• Mepha Parma AG, Switzerland: collaborator
• GlaxoSmithKline AG, Switzerland: collaborator

Study Sites (1)

Dep. of Oral and Maxillofacial Surgery, Bern University Hospital

Bern, CH-3011, Switzerland

Location

Related Publications (10)

• Peterson LJ, Booth DF. Efficacy of antibiotic prophylaxis in intraoral orthognathic surgery. J Oral Surg. 1976 Dec;34(12):1088-91.

  PMID: 1069110 BACKGROUND

• Martis C, Karabouta I. Infection after orthognathic surgery, with and without preventive antibiotics. Int J Oral Surg. 1984 Dec;13(6):490-4. doi: 10.1016/s0300-9785(84)80019-8.

  PMID: 6439657 BACKGROUND

• Yrastorza JA. Indications for antibiotics in orthognathic surgery. J Oral Surg. 1976 Jun;34(6):514-6.

  PMID: 1063838 BACKGROUND

• Chole RA, Yee J. Antibiotic prophylaxis for facial fractures. A prospective, randomized clinical trial. Arch Otolaryngol Head Neck Surg. 1987 Oct;113(10):1055-7. doi: 10.1001/archotol.1987.01860100033016.

  PMID: 3304348 BACKGROUND

• Hotz G, Novotny-Lenhard J, Kinzig M, Soergel F. Single-dose antibiotic prophylaxis in maxillofacial surgery. Chemotherapy. 1994 Jan-Feb;40(1):65-9. doi: 10.1159/000239173.

  PMID: 8306818 BACKGROUND

• Merten HA, Halling F. [Perioperative antibiotic prophylaxis in maxillofacial surgery]. Infection. 1993;21 Suppl 1:S45-8. doi: 10.1007/BF01710343. German.

  PMID: 8314293 BACKGROUND

• Abubaker AO, Rollert MK. Postoperative antibiotic prophylaxis in mandibular fractures: A preliminary randomized, double-blind, and placebo-controlled clinical study. J Oral Maxillofac Surg. 2001 Dec;59(12):1415-9. doi: 10.1053/joms.2001.28272.

  PMID: 11732026 BACKGROUND

• Folkestad L, Granstrom G. A prospective study of orbital fracture sequelae after change of surgical routines. J Oral Maxillofac Surg. 2003 Sep;61(9):1038-44. doi: 10.1016/s0278-2391(03)00316-1.

  PMID: 12966479 BACKGROUND

• Gerlach KL, Pape HD. [Studies on preventive antibiotics in the surgical treatment of mandibular fractures]. Dtsch Z Mund Kiefer Gesichtschir. 1988 Nov-Dec;12(6):497-500. No abstract available. German.

  PMID: 3253045 BACKGROUND

• National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

  PMID: 11904577 BACKGROUND

Related Links

• Click here for more information about the definition of Surgical Site Infections

MeSH Terms

Conditions

Surgical Wound Infection; Facial Injuries; Orbital Fractures; Zygomatic Fractures; Mandibular Fractures

Interventions

Amoxicillin-Potassium Clavulanate Combination; Amoxicillin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Maxillofacial Injuries; Skull Fractures; Fractures, Bone; Jaw Fractures

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Olivier Lieger, MD, DMD

  Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Tateyuki Iizuka, MD, DDS, PhD

  Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: January 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

CH (1)