Trial Outcomes & Findings for Antibiotic Prophylaxis in Orthopaedic Traumatology (NCT NCT00610987)
NCT ID: NCT00610987
Last Updated: 2015-06-12
Results Overview
The primary endpoint was infection.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.
Results posted on
2015-06-12
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
71
|
|
Overall Study
COMPLETED
|
75
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Prophylaxis in Orthopaedic Traumatology
Baseline characteristics by cohort
| Measure |
Cefazolin
n=75 Participants
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
n=71 Participants
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
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 19.1 • n=93 Participants
|
50.5 years
STANDARD_DEVIATION 20.5 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 19.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.The primary endpoint was infection.
Outcome measures
| Measure |
Cefazolin
n=75 Participants
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
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Total Wound Infections
|
4 participants
|
9 participants
|
Adverse Events
Cefazolin
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cefazolin
n=75 participants at risk
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
n=71 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infections
|
20.0%
15/75 • Number of events 15
|
7.0%
5/71 • Number of events 5
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/75
|
4.2%
3/71 • Number of events 3
|
|
Injury, poisoning and procedural complications
trauma
|
1.3%
1/75 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Surgical and medical procedures
implant problems
|
1.3%
1/75 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Vascular disorders
vascular
|
0.00%
0/75
|
2.8%
2/71 • Number of events 2
|
|
General disorders
General disorders including death
|
1.3%
1/75 • Number of events 1
|
11.3%
8/71 • Number of events 8
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brett Crist
University of Missouri, Department of Orthopaedics
Phone: 573-882-6562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place