Antibiotic Prophylaxis in Orthopaedic Traumatology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610987
First received: January 24, 2008
Last updated: July 10, 2014
Last verified: July 2014

January 24, 2008
July 10, 2014
January 2008
January 2014   (final data collection date for primary outcome measure)
Wound infections [ Time Frame: at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610987 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antibiotic Prophylaxis in Orthopaedic Traumatology
Antibiotic Prophylaxis in Orthopaedic Traumatology: A Prospective, Randomized Trial of Duration of Administration

It has been established that providing antibiotic prophylaxis after closed fracture fixation with implants or prosthetic devices has beneficial effects. However, the optimal duration of antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial effects of additional doses. Our proposed study is intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment of closed fractures. We will randomly assigned patients into two groups, hopefully differentiated only by the duration of antibiotic administration (single dose vs. 24 hours). We will follow these patients until fracture healing and determine if there is a difference in the incidence of infection.

The proposed study is a prospective, randomized, double-blinded clinical trial intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the internal fixation of closed fractures. Our hypothesis is that there will be no difference in the incidence of infection between single-dose versus 24 hours of antibiotic prophylaxis. The null hypothesis is that multiple-dose antibiotic prophylaxis will have a decreased incidence of infection.

Research Design:

A prospective, randomized, double-blinded clinical trial will be conducted to evaluate the duration of antibiotic prophylaxis. After investigators obtain Institutional Review Board approval, recruited patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. If a tourniquet is used, the cefazolin will be administered at least 10 minutes prior to inflation. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours. Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo. Group assignments will not be disclosed to the evaluators responsible for clinical examination or to the patients until the end of the study.

Either an orthopaedic surgeon or nurse practitioner will evaluate the patients for the development of a wound infection. Follow-up will occur at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs. Wound infection will be defined as one or more of the classic signs and symptoms of inflammation (rubor, calor, tumor, dolor) together with purulent drainage at the operative site. Wound infections will be classified either as superficial (infection of the skin or subcutaneous tissue, not communicating with the bone) or deep (infection that reached bone or material implanted for osteosynthesis). Bacteriological cultures will be obtained in the event of infectious complications, but wound infections will be diagnosed clinically.

Several studies have demonstrated that there are numerous patient-related and treatment-related factors that predispose to infectious complications. We will use several of these factors to assign a risk score to each of the enrolled patients. Each factor will be worth one point for a total score ranging from 0 (lowest risk) to 7 (highest risk). The risk factors are: 1) smoking; 2) age >65; 3) diabetes mellitus; 4) obesity (BMI >35); 5) duration of surgery >3 hours; 6) urinary catheterization (0=no catheter, 1=catheter <48 hours, 2=catheter >48 hours).

Statistical evaluation will be conducted by Student's t-test for patient characteristics and chi square analysis for infection rates. The relation between wound infection and the various possible risk factors will be assessed by forward stepwise logistic regression analysis. Significance will be defined at the P < 0.05 level.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fractures, Closed
  • Wounds and Injuries
  • Drug: cefazolin
    Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.
    Other Name: cefazolin brand name = Kefzol
  • Drug: Placebo
    Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo.
  • Active Comparator: 1
    Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
    Intervention: Drug: cefazolin
  • Placebo Comparator: 2
    Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients 18 years or older;
  • Scheduled for primary osteosynthesis or placement of a prosthetic device in the treatment of closed limb fractures;
  • Ability to give informed consent.

Exclusion Criteria:

  • Known hypersensitivity to cephalosporins;
  • Antimicrobial use or symptoms of infection in the week before surgery;
  • Pregnancy;
  • Immunosuppressive treatment;
  • Inability to give informed consent.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610987
IRB1089017
No
Brett Crist, University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Brett D Crist, MD University of Missouri-Columbia
University of Missouri-Columbia
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP