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Antibiotic Prophylaxis in Orthopaedic Traumatology

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ClinicalTrials.gov Identifier: NCT00610987
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fractures, Closed
Wounds and Injuries
Interventions Drug: cefazolin
Drug: Placebo
Enrollment 178
Recruitment Details 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 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.
Arm/Group Title Cefazolin Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 75 71
Completed 75 71
Not Completed 0 0
Arm/Group Title Cefazolin Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 75 71 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 71 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
  73.3%
37
  52.1%
92
  63.0%
>=65 years
20
  26.7%
34
  47.9%
54
  37.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 71 participants 146 participants
48.9  (19.1) 50.5  (20.5) 49.8  (19.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 71 participants 146 participants
Female
30
  40.0%
39
  54.9%
69
  47.3%
Male
45
  60.0%
32
  45.1%
77
  52.7%
1.Primary Outcome
Title Number of Participants With Total Wound Infections
Hide Description The primary endpoint was infection.
Time Frame at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cefazolin Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 75 71
Measure Type: Number
Unit of Measure: participants
4 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cefazolin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.12
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cefazolin Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cefazolin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cefazolin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/75 (24.00%)      22/71 (30.99%)    
General disorders     
General disorders including death *  1/75 (1.33%)  1 8/71 (11.27%)  8
Infections and infestations     
Infections   15/75 (20.00%)  15 5/71 (7.04%)  5
Injury, poisoning and procedural complications     
trauma *  1/75 (1.33%)  1 2/71 (2.82%)  2
Renal and urinary disorders     
Urinary tract infection *  0/75 (0.00%)  0 3/71 (4.23%)  3
Surgical and medical procedures     
implant problems *  1/75 (1.33%)  1 2/71 (2.82%)  2
Vascular disorders     
vascular *  0/75 (0.00%)  0 2/71 (2.82%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cefazolin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/75 (0.00%)      0/71 (0.00%)    
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
Responsible Party: Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00610987     History of Changes
Other Study ID Numbers: IRB1089017
First Submitted: January 24, 2008
First Posted: February 8, 2008
Results First Submitted: February 12, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015