Trial Outcomes & Findings for Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair (NCT NCT01273818)
NCT ID: NCT01273818
Last Updated: 2014-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
276 participants
Primary outcome timeframe
within the first 30 days after surgery
Results posted on
2014-12-29
Participant Flow
Recruitment period begins in Jan 2011. This period will be completed when record of minimum number participants ( according to power analysis) in each arm is completed.Location is surgery clinic of our hospital.
Totaly, 24 patients who were known using any kind of antibiotics for any reason just prior to surgery or just after the surgery and having history of allergic reactions to antibiotics used in this study were excluded.
Participant milestones
| Measure |
Gentamicin
Gentamicin arm: application of 80 mg gentamycin topically
|
Cefazolin
Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
|
Gentamicin+ Cefazolin Sodium
Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
87
|
98
|
91
|
|
Overall Study
NOT COMPLETED
|
13
|
2
|
9
|
Reasons for withdrawal
| Measure |
Gentamicin
Gentamicin arm: application of 80 mg gentamycin topically
|
Cefazolin
Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
|
Gentamicin+ Cefazolin Sodium
Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
13
|
2
|
9
|
Baseline Characteristics
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
Baseline characteristics by cohort
| Measure |
Gentamicin
n=87 Participants
Gentamicin arm: application of 80 mg gentamycin topically
|
Cephazolin
n=98 Participants
Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
|
Gentamicin+ Cefazolin Sodium
n=91 Participants
Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
|
Total
n=276 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
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
196 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
|
Age, Continuous
|
50.39 years
STANDARD_DEVIATION 15.39 • n=93 Participants
|
49.60 years
STANDARD_DEVIATION 13.85 • n=4 Participants
|
50.36 years
STANDARD_DEVIATION 15.49 • n=27 Participants
|
50.10 years
STANDARD_DEVIATION 14.85 • n=483 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
259 Participants
n=483 Participants
|
|
Region of Enrollment
Turkey
|
87 participants
n=93 Participants
|
98 participants
n=4 Participants
|
91 participants
n=27 Participants
|
276 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: within the first 30 days after surgeryOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: within the 30 days after surgeryPatients were examined on postoperative 30 days for the presence of surgical site infection.
Outcome measures
| Measure |
Topical Gentamicin
n=87 Participants
Total number of patients to which topical gentamicin was applied for prophylaxis
|
Cefazolin IV
n=98 Participants
Total number of patients to which ceephazoline (İV) was applied for prophylaxis
|
Topical and iv
n=91 Participants
Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
|
|---|---|---|---|
|
Number of Infections in Each Study Arm
|
1 infections
|
3 infections
|
0 infections
|
Adverse Events
Gentamicin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cephazolin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gentamicin+ Cefazolin Sodium
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
Dr.Gaye Seker
S.B.Ankara Diskapi Yildirim Beyazit Education and Teaching Hospital
Phone: +905323360618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place