Trial Outcomes & Findings for The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures (NCT NCT02413034)
NCT ID: NCT02413034
Last Updated: 2016-08-03
Results Overview
Number of positive Tissue Cultures (7)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
14 days
Results posted on
2016-08-03
Participant Flow
Participant milestones
| Measure |
Control Group
No antibiotic prophylaxis
|
Study Group
Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
Baseline characteristics by cohort
| Measure |
Control Group
n=14 Participants
No antibiotic prophylaxis
|
Study Group
n=14 Participants
Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 12 • n=5 Participants
|
75 years
STANDARD_DEVIATION 12 • n=7 Participants
|
74 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysNumber of positive Tissue Cultures (7)
Outcome measures
| Measure |
Control Group
n=14 Participants
No antibiotic prophylaxis
|
Study Group
n=14 Participants
Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
|
|---|---|---|
|
Positive Cultures
|
7 cultures
|
7 cultures
|
PRIMARY outcome
Timeframe: 14 daysNumber of positive Sonication cultures (7)
Outcome measures
| Measure |
Control Group
n=14 Participants
No antibiotic prophylaxis
|
Study Group
n=14 Participants
Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
|
|---|---|---|
|
Sonication Cultures
|
7 cultures
|
7 cultures
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place