Clinical Trial: Antibiotic Prophylaxis in Orthopaedic Traumatology
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Antibiotic Prophylaxis in Orthopaedic Traumatology: A Prospective, Randomized Trial of Duration of Administration
Brief Summary: 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.
Detailed Summary:
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 un
Sponsor: University of Missouri-Columbia
Current Primary Outcome: 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. ]
Original Primary Outcome: Wound infections [ Time Frame: at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs. ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Missouri-Columbia
Dates:
Date Received: January 24, 2008
Date Started: January 2008
Date Completion:
Last Updated: May 28, 2015
Last Verified: May 2015
