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: May 28, 2015
Last verified: May 2015
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fractures, Closed
Wounds and Injuries
Interventions: Drug: cefazolin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
After IRB approval, patients undergoing ORIF of closed fractures that had a planned postoperative stay of at least 23 hours were randomized to either receiving 23 hours of cefazolin or a placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After IRB approval, patients undergoing ORIF of closed fractures that had a planned postoperative stay of at least 23 hours were randomized to either receiving 23 hours of cefazolin or a placebo.

Reporting Groups
  Description
Cefazolin

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.

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.

Placebo

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

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.


Participant Flow:   Overall Study
    Cefazolin     Placebo  
STARTED     75     71  
COMPLETED     75     71  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cefazolin

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.

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.

Placebo

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

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.

Total Total of all reporting groups

Baseline Measures
    Cefazolin     Placebo     Total  
Number of Participants  
[units: participants]
  75     71     146  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     55     37     92  
>=65 years     20     34     54  
Age  
[units: years]
Mean (Standard Deviation)
  48.9  (19.1)     50.5  (20.5)     49.8  (19.9)  
Gender  
[units: participants]
     
Female     30     39     69  
Male     45     32     77  



  Outcome Measures

1.  Primary:   Number of Participants With Total Wound Infections   [ Time Frame: at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Brett Crist
Organization: University of Missouri, Department of Orthopaedics
phone: 573-882-6562
e-mail: cristb@health.missouri.edu


No publications provided


Responsible Party: Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00610987     History of Changes
Other Study ID Numbers: IRB1089017
Study First Received: January 24, 2008
Results First Received: February 12, 2015
Last Updated: May 28, 2015
Health Authority: United States: Institutional Review Board